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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase of the study.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 746 |
| Start date | Wed Mar 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Nov 30 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Relapsing Multiple Sclerosis
Interventions
- Fenebrutinib
- Teriflunomide
- Placebo
Countries
Hong Kong, Italy, Finland, Poland, Kenya, Tunisia, Netherlands, Russia, Mexico, Portugal, United States, Serbia, Hungary, Argentina, Spain, Georgia, Dominican Republic, Ukraine, Peru, Germany, Switzerland, China, North Macedonia