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Fenebrutinib

DRUG10 trials

Sponsors

F. Hoffmann-La Roche AG, Hoffmann-La Roche, F. Hoffmann La Roche, Hoffmann La Roche

Conditions

Healthy ParticipantsMultiple Sclerosis, Primary ProgressiveNervous System DiseasesRelapsing Multiple SclerosisRelapsing multiple sclerosis (RMS)

Phase 1

Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
CompletedNCT03596632
Hoffmann-La RocheHealthy Participants
Start: 2018-07-27End: 2018-08-23Updated: 2018-12-06

Phase 2

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
Active, not recruitingNCT05119569
Hoffmann-La RocheRelapsing Multiple Sclerosis
Start: 2022-03-01End: 2026-12-30Updated: 2026-02-04
MULTIPLE SCLEROSIS
Active, not recruitingPACTR202208658682109
F. Hoffmann La RocheNervous System Diseases
Start: 2023-01-31Target: 102Updated: 2026-01-27
An Open-Label, Single-Arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents with Relapsing Multiple Sclerosis
RecruitingCTIS2024-519800-28-00
F. Hoffmann-La Roche AGRelapsing Multiple Sclerosis
Start: 2025-11-26Target: 8Updated: 2026-01-20
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
RecruitingNCT07161258
Hoffmann-La RocheRelapsing Multiple Sclerosis
Start: 2025-10-06End: 2029-02-13Target: 12Updated: 2026-03-06

Phase 3

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
Active, not recruitingNCT04544449
Hoffmann-La RocheMultiple Sclerosis, Primary Progressive
Start: 2020-10-26End: 2027-07-21Updated: 2026-03-27
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Active, not recruitingNCT04586010
Hoffmann-La RocheRelapsing Multiple Sclerosis
Start: 2021-03-17End: 2027-11-30Updated: 2026-02-17
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Active, not recruitingNCT04586023
Hoffmann-La RocheRelapsing Multiple Sclerosis
Start: 2021-03-24End: 2027-07-09Updated: 2026-03-16
A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) (FENhance)
RecruitingPACTR202212815145545
Hoffmann La RocheNervous System Diseases
Start: 2023-02-28Target: 736Updated: 2026-01-27
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
Active, not recruitingCTIS2022-502609-14-00
F. Hoffmann-La Roche AGRelapsing multiple sclerosis (RMS)
Start: 2020-12-09Target: 214Updated: 2026-01-23

Related Papers

Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study.
2025-08-013 citations
Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials
Neurology2025-04-214 citations
Impact of Fenebrutinib Treatment on MRI Outcomes and Cerebrospinal Fluid Penetrance in Multiple Sclerosis: Results from the Phase II FENopta Study (S31.004)
Neurology2024-04-091 citations