KFEB
| Elnök: | Dr. Bitter István | ||||||||||||||||||||||||||||||||||||||||||||||||
| Alelnök: | Dr. Fürst Zsuzsanna | ||||||||||||||||||||||||||||||||||||||||||||||||
| Titkárok: | Dr. Arányi Péter Dr. Reusz György |
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| Titkárság: | Jegesi Bernadett Kovács Csaba Antalné Edit |
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| Telefon: | (+36 1) 795-4873 (+36 1) 795-1195 |
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| E-mail: | kfebtitkarsag@bm.gov.hu | ||||||||||||||||||||||||||||||||||||||||||||||||
| SUSAR beküldéséhez: | safetyreport@bm.gov.hu | ||||||||||||||||||||||||||||||||||||||||||||||||
| Bizottsági ülések: |
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A Bizottság tagjai
| Elnök: | Dr. Bitter István pszichiáter, neurológus, klinikai farmakológus |
| Alelnök: | Dr. Fürst Zsuzsanna farmakológus, klinikai farmakológus |
| Titkárok: | Dr. Arányi Péter biokémikus Dr. Reusz György csecsemő- és gyermekgyógyász, nefrológus, hipertonológus |
| Tagok: | Dr. Blaskó György belgyógyász, klinikai farmakológus, gasztroenterológus Dr. Borsodi Anna biokémikus Dr. Czobor Pál biológus, klinikai biostatisztikus Dr. Dobó István sebész Dr. Egri László kézsebész, traumatológus, teológus Dr. Farsang Csaba belgyógyász, nefrológus, hipertonológus, klinikai farmakológus Dr. Gyurkovits Kálmán csecsemő- és gyermekgyógyász, gyermektüdőgyógyász, klinikai farmakológus, gasztroenterológus Dr. Herold Róbert pszichiáter Dr. Hunyadi János bőrgyógyász, allergológus, klinikai immunológus Dr. Kiss Emese Virág reumatológus, belgyógyász, allergológus-klinikai immunológus Dr. Kiss Róbert Gábor kardiológus, belgyógyász Dr. Komoly Sámuel neurológus Dr. Lakatos Péter belgyógyász, endokrinológus Dr. Ludwig Endre infektológus, belgyógyász, klinikai farmakológus Dr. Mangel László Csaba pszichiáter, klinikai onkológus, radioterapeuta Dr. Maráz Anikó sugárterapeuta, klinikai onkológus, klinikai farmakológus Dr. Nagy Ágnes hematológus, belgyógyász Dr. Orodán Mária jogász Dr. Orosz Gábor Béla teológus, lelkész Dr. Póka Róbert nőgyógyász, klinikai onkológus Dr. Réthelyi János pszichiáter, klinikai genetikus Dr. Rosta András onkológus, belgyógyász Dr. Sipos Ildikó neurológus Dr. Tarnai Julianna reumatológus, klinikai farmakológus |
| Állandó meghívottak: | Dr. Bácsy Ernő ETT Dr. Borvendég János belgyógyász, klinikai farmakológus Dr. Hajdú Ágnes Zita OGYÉI Szántai Anita Magyar Sclerosis Multiplexes Betegekért Alapítvány (MSMBA) |
A Külső Szakértői Bizottság tagjai
Dr. Bereczki Dániel neurológus, pszichiáter
Dr. Csiba László neurológus, pszichiáter
Dr. Demetrovics Zsolt alkalmazott egészségpszichológiai szakpszichológus
Dr. Farkas Ágnes szemész
Dr. Fülesdi Béla neurológus, aneszteziológus
Dr. Gera István fogorvos, parodontológus
Dr. Holló Péter bőrgyógyász, onkológus
Dr. Járay Zoltán belgyógyász, kardiológus, klinikai farmakológus
Dr. Julesz János belgyógyász, endokrinológus
Dr. Kis Zoltán virológus
Dr. Kovács Gábor belgyógyász, pulmonológus, klinikai onkológus
Dr. Molnár Márk neurológus, pszichofiziológus
Dr. Németh Péter immunológus
Dr. Oberna Ferenc fül-orr-gégész, szájsebész, fej-nyaksebész
Dr. Péley Bernadette pszichológus
Dr. Prinz Gyula belgyógyász, infektológus
Dr. Somogyi Anikó belgyógyász, klinikai farmakológus, endokrinológus
Dr. Sulyok Gabriella reumatológus
Dr. Süveges Ildikó szemész
Dr. Szekanecz Zoltán reumatológus, belgyógyász, immunológus
Dr. Szijártó Attila sebész
Dr. Szűcs Nikolette belgyógyász, endokrinológus
Dr. Tóth Judit jogász
Dr. Vértes András kardiológus
Dr. Vidnyánszky Zoltán biológus
Intézkedések a járvány idejére
– Tájékoztatás az ETT KFEB különleges eljárásáról a járványügyi készültség idején (2020.11.03.)
Tájékoztatás szponzorok és benyújtók számára a Bizottság járványügyi veszélyhelyzet alatt követett eljárási rendjéről
Bizottsági tagjaink és a titkárság munkatársai – akik erre engedélyt kapnak – részben „home office” munkarend szerint dolgoznak, a titkárságon ügyeletet tartva. A Bizottság mindent megtesz annak érdekében, hogy felelősségteljes feladatait el tudja látni.
A személyes találkozások korlátozása a jelenlegi járvány helyzetben alapvető fontosságú. Ezért a Bizottság rendszeres értekezleteit video- és telefonkonferenciákkal helyettesítjük, nagyjából tartva a honlapunkon előre meghirdetett bizottsági ülésrend időbeosztását.
A Bizottság Plenum ülésein rendszerint mind a 30 tag részt vesz, a videokonferenciákon is törekszünk e létszám a bevonására, ezt azonban technikai nehézségek gátolhatják.
A sürgős ügyeket Quorum ülésrend szerint tartjuk (235/2009. X.2. Korm.rend. 24§), 5-8 résztvevővel, hogy ezek a megbeszélések biztonságosan levezethetők legyenek. A résztvevők köre a megbeszélt anyagok tárgya szerint módosul.
Az általában megszokott rövid telefonos konzultációk, amelyeket a benyújtók a könnyen korrigálható hiányosságok kérdésében gyakran kezdeményeztek, a mostani helyzetben nem lehetségesek. A Bizottság javasolja a honlapunkon megjelentetett irányelvek és gyakorlati tanácsok pontos követését.
A VHP+ és VHP+pilot eljárások rövid határidőit az esetek nagy részében a járványveszélyhelyzet alatt a Bizottság nem lesz képes tartani. Természetesen az esetleges COVID-19 fertőzéssel kapcsolatosan kezdeményezett vizsgálatokat soron kívül, a lehető leggyorsabban fogja értékelni a Bizottság. Kérjük a benyújtók szíves megértését.
A CTFG által kidolgozott guideline-okat a Bizottság a következőkben figyelembe fogja venni.
Módszertani levelek
– BETEGKÁRTYA szakmai-etikai követelmények (2015.12.15.)
Ajánlások klinikai gyógyszervizsgálatot kezdeményezőknek
A bioszimiláris igazolására tervezett klinikai gyógyszervizsgálatok szakmai-etikai értékelése (2022.11.28.)
Ajánlás a klinikai vizsgálatok betegtájékoztatóinak adatvédelmi követelményeiről a GDPR kapcsán (2021.05.31.)
Tájékoztatás a Gyógyszerrendelet alapján beadandó vizsgálati kérelmek benyújtóinak
National requirements for initial submissions/
Originális vizsgálati kérelmekre vonatkozó nemzeti követelmények
The list of required documentation and information is set out in Annex I. of REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
In particular:
The application dossier for an application limited to Part I of the assessment report referred to in Article 11 shall be limited to sections B to J and Q of Annex I.
National requirements related to Part I:
Protocol synopsis in Hungarian language preferably a certified translation of the original protocol synopsis (not to be confused with trial summary for lay people);
The application dossier for an application limited to Part II of the assessment report referred to in Article 11 and the application dossier for an application referred to in Article 14 shall be limited to sections K to R of Annex I.
National requirements related to Part II of the application dossier in particular include
CV of PI’s and co-investigators according to the templates proposed by CTEG as modified for Hungary and available on our homepage;
Site suitability templates according to the templates proposed by CTEG as modified for Hungary and available on our homepage;
Patient emergency card as addenda to the (main) ICF according to the specifications available on our homepage;
All recruitment material in their final forms in Hungarian language;
Protocol signature pages signed by PI”s and Co-investigators;
A list in Hungarian language of Part II documents submitted in order to help the lay members of the Ethics Committee for Clinical Pharmacology to evaluate the submission.
In case both Part I and Part II application dossiers are submitted at the same time, all documents listed above should be provided for evaluation.
AZ ENGEDÉLY IRÁNTI KÉRELEMHEZ SZÜKSÉGES DOKUMENTÁCIÓ AZ EURÓPAI PARLAMENT ÉS A TANÁCS 536/2014/EU RENDELETE (2014. április 16.) az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatairól és a 2001/20/EK irányelv hatályon kívül helyezéséről I. Melléklete szerint.
Részletezve:
Az értékelő jelentés I. részében szereplő szempontokra korlátozódó engedélyezéshez szükséges dokumentáció I. Melléklet B–J. és Q. szakaszára korlátozódik.
Az értékelő jelentés I. részéhez kapcsolódó magyar tagállami követelmény:
Magyar nyelvű protokoll szinopszis az eredeti protocol synopsis lehetőleg hivatalos fordítása, nem tévesztendő össze a laikusok számára készített vizsgálati összefoglalóval
Az értékelő jelentés II. részében szereplő szempontokra korlátozódó engedélyezéshez szükséges dokumentáció az I. Melléklet K–R. szakaszára korlátozódik.
Az értékelő jelentés II. részéhez kapcsolódó magyar tagállami követelmények:
A vizsgálatvezetők és a társvizsgálók szakmai önéletrajzai a honlapunkon megtalálható, a Magyarországi kívánalmakhoz igazított CTEG templát szerint;
A vizsgálatvezetők és a társvizsgálók által aláírt protocol signature oldalalak;
A vizsgálóhelyek megfelelőségét igazoló dokumentumok, a honlapunkon megtalálható, a Magyarországi kívánalmakhoz igazított CTEG templát szerint;
A fő tájékozott belegyezési dokumentum mellékleteként felcsatolt betegkártya, a honlapunkon található kívánalmaknak megfelelően elkészítve;
Minden toborzó dokumentum végleges formában, magyar nyelven;
Az értékelő jelentés II. részéhez benyújtott dokumentumok listája, melynek célja a KFEB nem orvos tagjai számára történő segítségnyújtás a beterjesztett dokumentumok értékeléséhez.
Amennyiben a vizsgálati kérelem I. és a II. részét egyidejűleg nyújtják be, minden fent felsorolt dokumentumot egyszerre kell a Bizottság rendelkezésére bocsájtani.
TEMPLATES:
Investigator Curriculum Vitae
Site Suitability Form
Az ETT KFEB által tárgyalt klinikai vizsgálati kérelmek (2022)
| Sorszám és cím |
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| 1. AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM) |
| 2. A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction |
| 3. A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria |
| 4. A Phase 2B prospective, blinded, randomized, placebo controlled, international multicenter study to assess restoration of coronary artery blood flow and resolution of ST segment deviation after a single subcutaneous injection of RUC-4 in subjects with ST-elevation myocardial infarction presenting in the ambulance (pre-hospital setting) |
| 5. A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer |
| 6. An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers |
| 7. A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation |
| 8. Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease |
| 9. Evaluation of the bioequivalence of two products containing aripiprazole: Aripiprazole LAI powder and solvent for prolonged-release suspension for intramuscular injection, 400mg, Greece (Test) vs. ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension, for intramuscular use, 400mg, USA (Reference). A multicentric, multi-national, open-label, randomized, multiple dose, two-period, crossover pharmacokinetic study in schizophrenic patients |
| 10. A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) |
| 11. READY 2: A PHASE 3, OPEN LABEL, SINGLE ARM STUDY ON THE USE OF CUSA-081 FOR DYSFUNCTIONAL CENTRAL VENOUS ACCESS DEVICES (CVADs) |
| 12. A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T) |
| 13. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib |
| 14. OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS |
| 15. A phase Ib/II open label dose confirmation, proof of concept study of siremadlin in combination with venetoclax plus azacitidine in unfit adult AML participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment and in participants with newly diagnosed unfit AML presenting with high-risk clinical features. |
| 16. A randomised, double-blind, placebo-controlled, parallel group, dosefinding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis |
| 17. A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE AFTER CONVERSION FROM AN ERYTHROPOIESIS-STIMULATING AGENT |
| 18. A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome |
| 19. A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAIVE TO ERYTHROPOIESIS-STIMULATING AGENTS |
| 20. AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM) |
| 21. A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus |
| 22. A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer |
| 23. Master protocol of two randomized, double blind, placebo-controlled, multicenter, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO) |
| 24. Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI P/0145/2019 |
| 25. A PHASE IIIB, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED STUDY OF THE EFFECTIVENESS AND SAFETY OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT TREAT & EXTEND IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (DIAGRID) |
| 26. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy |
| 27. A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). |
| 28. A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD) |
| 29. A Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea® in Patients With Neovascular Age Related Macular Degeneration (ALTERA) |
| 30. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA |
| 31. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 IN COMBINATION WITH RANIBIZUMB ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA |
| 32. A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH ATEZOLIZUMAB AS MAINTENANCE THERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL-CELL LUNG CANCER (ES-SCLC) FOLLOWING FIRST-LINE INDUCTION THERAPY WITH CARBOPLATIN, ETOPOSIDE AND ATEZOLIZUMAB |
| 33. AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER SPONSORED AVELUMAB CLINICAL STUDIES |
| 34. AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA |
| 35. Phase 1 Pharmacokinetics and Safety Study of Oral Soticlestat in Participants with Moderate or Severe Hepatic Impairment and Normal Hepatic Function |
| 36. AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS >= 18 AND =< 80 WITH ACTIVE DERMATOMYOSITIS. |
| 37. A Phase 1b study in patients with acromegaly or functioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of Debio 4126, a 12-week prolonged-release octreotide formulation |
| 38. A Phase 1, first-in-human, three-part, randomized, double-blind, placebocontrolled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAR443726 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis. |
| 39. postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy |
| 40. A Three-Part, Phase 1, Randomized, Controlled, Dose-Escalation Study of INT-787 Following Single or Multiple Dose Administration in Healthy Subjects |
| 41. A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022) |
| 42. A randomized double blind placebo controlled multicenter study to assess the efficacy and tolerability of tolperisone as add on treatment with standardized NSAID of acute non specific low back pain. |
| 43. Phase I /II, open label, dose escalation part (phase I) followed by non-comparative expansion part (phase II), multi-centre study, evaluating safety, pharmacokinetics and efficacy of S65487, a Bcl2 inhibitor combined with azacitidine in adult patients with previously untreated acute myeloid leukemia not eligible for intensive treatment |
| 44. A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination with Anti-Cancer Agents in Adult Participants with Metastatic Pancreatic Adenocarcinoma |
| 45. A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients. |
| 46. Comparison of the preventive painkiller effect of etoricoxib and celecoxib after M3M surgery: A randomized, double-masked clinical trial |
| 47. A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) |
| 48. A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy. |
| 49. A Randomized, Double-Blind, Placebo controlled Study Assessing the Longterm Effect of Dupilumab on Prevention of Lung Function Decline in Patients with Uncontrolled Moderate to Severe Asthma |
| 50. An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects with Relapsed or Refractory Small Cell Lung Cancer (SCLC) |
| 51. A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) |
| 52. A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon) |
| 53. A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly |
| 54. LuCa-MERIT-1: First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer. |
| 55. A randomized, double-blind, parallel group, placebo-controlled, multicenter Phase 3 trial to evaluate the efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with active lupus nephritis (SIRIUS-LN) |
| 56. A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid |
| 57. A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity |
| 58. A Phase III, Randomized, Doubleblind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Nonsmall Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinumbased Concurrent Chemoradiation Therapy (PACIFIC-8) |
| 59. A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) |
| 60. MAGNETISMM-7 A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO ARE MINIMAL RESIDUAL DISEASE POSITIVE AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION |
| 61. Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies |
| 62. A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatric subjects |
| 63. A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea® in Subjects with Neovascular (wet) Age related Macular Degeneration (ALVOEYE) |
| 64. A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13 |
| 65. IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction |
| 66. A Phase I, Open-Label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children >= 5 to 11 Years of Age with Mild, Moderate, or Severe Asthma (TRAILHEAD) |
| 67. A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3) |
| 68. A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation |
| 69. A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction |
| 70. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease |
| 71. A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) (CAPItello-280) |
| 72. A randomised, openlabel, multi-centre, two-arm Phase 3 study comparing futuximab/modotuximab in combination with trifluridine/tipiracil to trifluridine/tipiracil single agent with a Safety Lead-In part in participants with KRAS/NRAS and BRAF wild type metastatic colorectal cancer previously treated with standard treatment and anti-EGFR therapy (COLSTAR) |
| 73. A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE |
| 74. A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) |
| 75. A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation |
| 76. A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease |
| 77. A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis |
| 78. A non-randomized, open-label, 2-part, parallel-cohort trial to evaluate 1) pharmacokinetics, safety, and tolerability of a single dose of BI 456906 in patients with cirrhosis and varying degrees of hepatic impairment relative to healthy subjects and 2) safety and tolerability of multiple doses of BI 456906 in patients with overweight/obesity with cirrhosis and varying degrees of hepatic impairment relative to patients with overweight/obesity without cirrhosis/hepatic impairment |
| 79. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis |
| 80. A phase III randomized, controlled, open-label, multicenter, global study of capmatinib in combination with osimertinib versus platinum – pemetrexed based doublet chemotherapy in patients with locally advanced or metastatic NSCLC harboring EGFR activating mutations who have progressed on prior EGFR-TKI therapy and whose tumors are T790M mutation negative and harbor MET amplification (GEOMETRY-E) |
| 81. A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE |
| 82. A Subject-Blinded First-In-Human Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of AST-004 As a Short Intravenous Infusion in Healthy Adult Subjects |
| 83. A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)” |
| 84. A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE” |
| 85. A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED ≥ 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS ON EMICIZUMAB PROPHYLAXIS” |
| 86. Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group” |
| 87. A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy” |
| 88. A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTEC93/GOG-3064/ENGOT-en15)” |
| 89. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib” |
| 90. A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)” |
| 91. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib” |
| 92. A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II” |
| 93. A PHASE Ia/Ib DOSE-ESCALATION AND DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTICANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION” |
| 94. A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours” |
| 95. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER |
| 96. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER |
| 97. A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. |
| 98. A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF) |
| 99. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
| 100. A multi-center, randomized, double-blind, placebo controlled, parallelgroup Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE) |
| 101. A Phase 2, Randomised, Double-Blind, Placebo and Active Comparator-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD5718 Given Orally Once Daily for Twelve Weeks in Adults with Moderate-to-Severe Uncontrolled Asthma |
| 102. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR TREATMENT OF RET-MUTATED MEDULLARY THYROID CANCER |
| 103. An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with Ruxolitinib in Janus associated Kinase Inhibitor (JAKi) Treatment-Naive Myelofibrosis (MF) Subjects and Subjects with MF who have a Suboptimal Response to Ruxolitinib |
| 104. Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) |
| 105. Part I. A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 106. Part II. A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 107. An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma |
| 108. A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis |
| 109. An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy |
| 110. A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) |
| 111. A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia |
| 112. An adaptive, randomized, double-blind, dose exploration, parallel group, placebo-controlled, multicenter phase 2 trial to evaluate the efficacy, safety and tolerability of LNP023 in combination with standard-of-care with and without oral corticosteroids in patients with active lupus nephritis Class III-IV, +/- V |
| 113. A PHASE 2/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UNESBULIN IN UNRESECTABLE OR METASTATIC, RELAPSED OR REFRACTORY LEIOMYOSARCOMA |
| 114. A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis |
| 115. A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02) |
| 116. A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE 301) |
| 117. A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects with Chronic Kidney Disease with Associated Severe Pruritus |
| 118. A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera |
| 119. A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| 120. A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) |
| 121. A Parallel Group Multiple Ascending Dose, Phase 1, Double-Blind, 5-Cohort Study to Investigate the Safety and Pharmacokinetics of NTRX 07 in Male or Female Healthy Volunteers and Patients with Early Alzheimer’s Disease (AD), with an Exploratory Fed-Fasted Assessment |
| 122. A phase 3, multicenter, multinational, randomized, double-blind, doubledummy, active-comparator study to evaluate the efficacy and safety of venglustat in adult and pediatric patients with Gaucher disease Type 3 (GD3) who have reached therapeutic goals with Enzyme Replacement Therapy (ERT) |
| 123. Part I. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure |
| 124. Part II A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure |
| 125. A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose and annual revaccination doses of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above. |
| 126. MAJIC: A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| 127. KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer |
| 128. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors do not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting whose Tumors do Express PD-L1 |
| 129. A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa |
| 130. Part I. Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 |
| 131. A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria |
| 132. A Randomized, Parallel Design, Multiple-Site Study to Evaluate the noninferiority of generic Clotrimazole 10mg/g cream (Antibiotice SA) compared to Canesten® 10mg/g cream in Patients with Tinea Pedis |
| 133. A Phase II, double-blind, randomized, multiple dose, cross over, threetreatment, three-period, six sequence placebo controlled trial to evaluate efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of glycopyrronium (bromide) in children from 6 to less than 12 years of age with asthma |
| 134. A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis |
| 135. A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102) |
| 136. A phase Ia/Ib, open label, dose-escalation study of the combination of BI 907828 with BI 754091 (ezabenlimab) and BI 754111 and the combination of BI 907828 with BI 754091 (ezabenlimab) followed by expansion cohorts, in patients with advanced solid tumors |
| 137. A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers |
| 138. A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera |
| 139. A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naive Subjects with Advanced or Metastatic PD-L1 High (TPS .50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08) |
| 140. A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation |
| 141. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease |
| 142. A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines |
| 143. Study of Females Exposed to Eleclazine |
| 144. A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744 |
| 145. A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure |
| 146. A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) |
| 147. A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366). |
| 148. A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314) |
| 149. A Phase II/III, prospective, multi-center, randomized, 4-week, doubleblind, placebo-controlled study, designed to determine the safety, tolerability, EEG effects and efficacy of oral doses of 30 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication. |
| 150. ASCEND-NASH: A PHASE 2B, RANDOMIZED, MULTI-CENTER, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRV431 IN ADULT SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS AND ADVANCED LIVER FIBROSIS |
| 151. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder |
| 152. A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD) |
| 153. A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction. |
| 154. An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer |
| 155. A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy |
| 156. Phase I, Single Blind, Single Escalating Doses Study to evaluate the Safety, Tolerability, Pharmacokinetics and Imaging (CT) Performance of Orally Administered ImageBAT in Healthy Subjects |
| 157. A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) |
| 158. A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease |
| 159. Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants withoverweight or obesityand type 2 diabetes |
| 160. A Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study of DRL_AB, US licensed Reference Abatacept (Orencia®) and EU approved Reference (Orencia®), Administered by the Intravenous Route to Male Normal Healthy Volunteers |
| 161. D3-vitaminnal, L-lizinnel és süngomba-kivonattal (Hericium erinaceus) dúsított sajtféleség funkiconális hatásának vizsgálata önkéntes résztvevőkön. |
| 162. ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults |
| 163. A randomized, Phase 3, open label study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM) |
| 164. A randomised, double-blind, parallel, multicentre, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 (proposed denosumab biosimilar) versus Prolia® (EU-sourced) in postmenopausal women with osteoporosis (SIMBA Study) |
| 165. Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight – a participant- and investigatorblinded and sponsor open-label study |
| 166. CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer |
| 167. A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy |
| 168. A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA |
| 169. A Phase 1 study to evaluate safety and tolerability of single and multiple ascending doses of XEN-101 |
| 170. First-in-Human, Double-Blind, Randomised, Vehicle-Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis |
| 171. A 52 week study comparing the efficacy and safety of once weekly IcoSema and once weekly semaglutide, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with a GLP 1 receptor agonist. COMBINE 2 |
| 172. A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis |
| 173. A Phase 1/2, open-label, multi-center study of the safety and efficacy of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies |
| 174. A Phase 2/3 Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema |
| 175. APPRAIS - A 24-week multicentre, randomized, double-blind, placebocontrolled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate |
| 176. Clinical study on the safety and efficacy of hydroxychloroquine administered daily as Hydroxychloroquine Meditop 200 mg film-coated tablets for 3 months in 24 patients with rheumatoid arthritis |
| 177. A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia |
| 178. A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-CF113 in the treatment of endometriosis versus placebo after 3 medication cycles followed by 3 open-label medication cycles |
| 179. Part I. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 180. Part II. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 181. ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation |
| 182. A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY |
| 183. An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II |
| 184. Part I (Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors |
| 185. Part II (Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors |
| 186. A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1) |
| 187. A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered filgotinib in subjects with ulcerative colitis in clinical remission |
| 188. A phase I, open-label, single-center, single-dose, parallel-group study to evaluate the pharmacokinetics of BV100 in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants |
| 189. A Phase 3b/4 Randomized, Double-blind, Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up) |
| 190. A double-blind, randomized, placebo-controlled multicenter study toinvestigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks in women with, or at high risk for developing hormone-receptor positive breast cancer |
| 191. Endothelial protection in convalecent COVID-19 patients. The effect of Sulodexide on serum levels of biomarkers for endothelial dysfunction. A prospective, randomized, placebo-controlled, investigator-initiated trial. |
| 192. A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness |
| 193. A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype |
| 194. A trial of prednisolone in combination with SPI-62 or placebo in subjects with polymyalgia rheumatica (PMR) |
| 195. A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase |
| 196. A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA |
| 197. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 |
| 198. Effectiveness and pharmacokinetic /pharmacodynamic study of Furazidin, prolonged- release tablets, 200 mg in the treatment of patients with uncomplicated lower urinary tract infections (acute or recurrent). FUTURE |
| 199. An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
| 200. A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease, treated with standard of care: cholinesterase inhibitors, memantine |
| 201. A multicenter, participant and investigator-blinded, randomized, placebo-controlled Phase 2a study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of TIN816 in the treatment of patients with sepsis-associated acute kidney injury |
| 202. An Open-label Extension Study to Evaluate Longterm Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT) |
| 203. A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, with and without Intermittent LowDose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large BCell Lymphoma (VITALIZE). |
| 204. A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19 |
| 205. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies |
| 206. A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 with Cosentyx® in Patients with Moderate to Severe Plaque Psoriasis |
| 207. A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial |
| 208. A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes |
| 209. Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy |
| 210. Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma |
| 211. A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer (SCLC) Patients (LAGOON Trial) |
| 212. A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Birch Pollen-induced Allergic Rhinoconjunctivitis with or without Asthma |
| 213. A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304) |
| 214. A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment |
| 215. KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation |
| 216. A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer |
| 217. PART I (2022-500302-18-00) A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures |
| 218. PART I (2022-500290-14-00) A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 219. PART II (2022-500290-14-00) A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 220. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Induction Study of ADS024 in Participants with Mild to Moderate Ulcerative Colitis (UC) followed by an Optional Open-Label Extension (OLE)" |
| 221. A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors |
| 222. A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer |
| 223. A pivotal Phase II randomised, multi-centre, open label study to evaluate the efficacy and safety of MB CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B cell lymphoma (R R DLBCL), who are not eligible for high dose chemotherapy and autologous stem cell transplantation |
| 224. A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma |
| 225. A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis |
| 226. A Phase 1, open-label, study to investigate the pharmacokinetics and safety of remibrutinib (LOU064) in participants with hepatic impairment compared to matched healthy participants with normal hepatic function |
| 227. Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study |
| 228. A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart Failure |
| 229. A Phase 1 Single Center Open-label, Non-randomized, Fixed Sequence Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of BV100 When Administered Alone and With Itraconazole |
| 230. PART I A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis |
| 231. PART II A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis |
| 232. A PHASE 2B RANDOMIZED, DOUBLE-BLIND, ACTIVE-AND PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE COMBINATION THERAPY WITH GUSELKUMAB AND GOLIMUMAB IN PARTICIPANTS WITH MODERATELY TO SEVERELYACTIVE CROHN’S DISEASE – DUET-CD |
| 233. A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 in Adult Participants With Schizophrenia |
| 234. A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension |
| 235. An open-label, non-randomized Phase I investigation of human ADME (absorption, distribution, metabolism and excretion) and absolute oral bioavailability of BI 907828 in patients with advanced solid tumours |
| 236. A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR |
| 237. Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment |
| 238. A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA |
| 239. PART I A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma |
| 240. PART II A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma |
| 241. AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED |
| 242. A PHASE 2B RANDOMIZED, DOUBLE-BLIND, ACTIVE-AND PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE COMBINATION THERAPY WITH GUSELKUMAB AND GOLIMUMAB IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS DUET-UC |
| 243. A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP) |
| 244. A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate to-severe asthma |
| 245. PART I A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults with Moderate or Severe Diabetic Foot Infections |
| 246. PART II A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults with Moderate or Severe Diabetic Foot Infections |
| 247. A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial investigating the efficacy, safety, and tolerability of two different doses of buntanetap or placebo in patients with early Parkinson’s disease |
| 248. PART I A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) |
| 249. PART II A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) |
| 250. Part I. A double-blind, randomized, placebo-controlled, interventional, multicenter, phase III clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB) |
| 251. Part II. A double-blind, randomized, placebo-controlled, interventional, multicenter, phase III clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB) |
| 252. Part I. A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2 |
| 253. Part II. A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2 |
| 254. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction (HFpEF) |
| 255. A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease |
| 256. A multicenter, randomized, double-blind, placebocontrolled, parallel-arm study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of negative symptoms of schizophrenia |
| 257. A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, "Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy |
| 258. A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up) |
| 259. Phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12-17 years of age) with moderate-to-severe plaque psoriasis Short Title: Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis |
| 260. A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma |
| 261. An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) |
| 262. Part I. A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION |
| 263. Part II. A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION |
| 264. A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients with Diabetic Kidney Disease |
| 265. An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy |
| 266. Part I Phase 3, single-arm, multicenter, multinational, open-label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged ≥ 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX |
| 267. Part II Phase 3, single-arm, multicenter, multinational, open-label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged ≥ 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX |
| 268. A multicenter study of secukinumab, with a randomized double-blind, placebo-controlled withdrawal-retreatment period, to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission |
| 269. A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer |
Módosítási kérelmek
| Hónap | Kérelmek száma |
| Január | 189 |
| Február | 148 |
| Március | 268 |
| Április | 124 |
| Május | 220 |
| Június | 170 |
| Július | 216 |
| Augusztus | 179 |
| Szeptember | 200 |
| Október | 164 |
| November | 180 |
| December | 142 (nem végleges!) |