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

Last updated: July 7, 2023
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

TX312871
  • Ages 18-55
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

*

Exclusion

Exclusion Criteria:

*

Study Design

Study Start date:
December 16, 2021
Estimated Completion Date:
April 30, 2026

Study Description

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.

Connect with a study center

  • Alpine Clinical Research Center

    Boulder, Colorado 80301
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.