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Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) — REMODEL-1  

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Summary

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05147220
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 3
Start date December 16, 2021
Completion date October 30, 2030
View Details
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