Trials / Active Not Recruiting
Active Not RecruitingNCT05147220
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,001 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
Detailed description
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants. The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS). The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years. A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remibrutinib | tablet taken orally |
| DRUG | Teriflunomide | capsule taken orally |
Timeline
- Start date
- 2021-12-16
- Primary completion
- 2026-04-30
- Completion
- 2030-10-30
- First posted
- 2021-12-07
- Last updated
- 2026-03-10
Locations
200 sites across 34 countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Georgia, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Poland, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05147220. Inclusion in this directory is not an endorsement.