Klinikai Farmakológiai Etikai Bizottság

KFEB

Elnök: Dr. Bitter István
Alelnök: Dr. Fürst Zsuzsanna
Titkárok: Dr. Arányi Péter
Dr. Reusz György
Titkárság: Jegesi Bernadett
Kovács Csaba Antalné Edit
Telefon: (+36 1) 795-4873
(+36 1) 795-1195
E-mail: kfebtitkarsag@bm.gov.hu
SUSAR beküldéséhez: safetyreport@bm.gov.hu
Bizottsági ülések:
Év Hónap Nap / ülések száma
2022. január 4 ülés
2022. február 4 ülés
2022. március 5 ülés
2022. április 4 ülés
2022. május 4 ülés
2022. június 5 ülés
2022. július 4 ülés
2022. augusztus 4 ülés
2022. szeptember 4 ülés
2022. október 5.
12.
19.
26.
2022. november 2.
9.
16.
23.
30.
2022. december 7.
14.
21.

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. 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. Németh Péter immunológus
Dr. Oberna Ferenc fül-orr-gégész, szájsebész, fej-nyaksebész
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. Vértes András kardiológus

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

Ajánlások klinikai gyógyszervizsgálatot kezdeményezőknek

Tájékoztatás a Gyógyszerrendelet alapján beadandó vizsgálati kérelmek benyújtóinak


A PART II dokumentumok beadásánál a Bizottság elvárja az „Investigator Curriculum Vitae” és a „Site Suitability Form” templátok kitöltését.

Ugyancsak szükséges egy, a Part II. dokumentumokat felsoroló magyar nyelvű kísérőlevél. Ebben ki kell térni arra, hogy a vizsgálatba kívánnak-e bevonni a magyar jog szerint korlátozottan cselekvőképes kiskorúakat, illetve cselekvőképességükben az egészségügyi ellátással összefüggő jogok gyakorlása tekintetében részlegesen korlátozott vagy cselekvőképtelen személyeket, és ha igen, készültek-e ennek megfelelő tájékoztatáson alapuló beleegyező nyilatkozatok az Egészségügyi törvény 159. § (4) bekezdés d) pontjában meghatározott személyek számára, továbbá elkészültek-e korcsoportok szerinti bontásban a magyar jog szerint kiskorúaknak szóló tájékoztatáson alapuló beleegyező nyilatkozatok és azokat felcsatolták-e a CTIS megfelelő helyére. Amennyiben alvizsgálatok is tervbe vannak véve, azok tájékoztatóit / tájékoztatáson alapuló beleegyező nyilatkozatait is be kell nyújtani, és azokat is fel kell sorolni a kísérőlevélben.

Célszerű minden más, a betegek számára készült dokumentumot is felsorolni, mivel ez segít elkerülni azt a hibát, hogy a végső etikai állásfoglalásból esetleg azok egy része kimarad.

TEMPLATES:
Investigator Curriculum Vitae
Site Suitability Form

Az ETT KFEB által tárgyalt klinikai vizsgálati kérelmek (2022)

Sorszám és cím
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

 
Módosítási kérelmek

Hónap Kérelmek száma
Január 189
Február 148
Március 268
Április 124
Május 220
Június 170
Július 216
Augusztus 179