Fenebrutinib (DrugBank: Fenebrutinib)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 5 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04586023 (ClinicalTrials.gov) | December 26, 2020 | 8/10/2020 | Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 2 | NCT04586010 (ClinicalTrials.gov) | December 18, 2020 | 8/10/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 3 | EUCTR2019-003919-53-GB (EUCTR) | 17/12/2020 | 26/11/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 4 | EUCTR2019-004857-10-FI (EUCTR) | 20/11/2020 | 03/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing multiple sclerosis (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Genentech, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Finland;Netherlands | ||
| 5 | NCT04544449 (ClinicalTrials.gov) | October 26, 2020 | 4/9/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis | A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis. | Multiple Sclerosis, Primary Progressive | Drug: fenebrutinib;Drug: ocrelizumab;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 946 | Phase 3 | United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom |