Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT05147220
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals (Responsible Party)
Last Update Posted: 2023-05-11
Brief Summary:
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis
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.
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: Remibrutinib
Drug: Teriflunomide
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-12-16 |
| Primary Completion (Estimated) | 2026-04-30 |
| Study Completion (Estimated) | 2030-10-30 |
| Enrollment (Estimated) | 800 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | CLOU064C12301 2020-005899-36 (EudraCT Number) |