Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
-
- STATUS
- Not Recruiting
-
- End date
- Aug 28, 2023
-
- participants needed
- 900
-
- sponsor
- Sanofi
For site information, send an email with site number to
Primary Contact
Investigational Site Number :8400025 (8.1 mi away) Contact
+173 other locationSummary
Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
Description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study.
Details
| Condition | Relapsing Multiple Sclerosis |
|---|---|
| Treatment | Teriflunomide HMR1726, SAR442168, Placebo to match SAR442168, Placebo to match Teriflunomide, Tolebrutinib, Placebo to match Tolebrutinib |
| Clinical Study Identifier | NCT04410991 |
| Sponsor | Sanofi |
| Last Modified on | 8 August 2022 |
Similar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer