Trials / Active Not Recruiting
Active Not RecruitingNCT05119569
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fenebrutinib | Fenebrutinib will be administered orally. |
| DRUG | Placebo | Placebo will be administered orally. |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2023-03-29
- Completion
- 2026-12-30
- First posted
- 2021-11-15
- Last updated
- 2026-02-04
- Results posted
- 2024-06-12
Locations
17 sites across 6 countries: United States, Bosnia and Herzegovina, Croatia, Czechia, Serbia, Slovakia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05119569. Inclusion in this directory is not an endorsement.