Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168
-
- STATUS
- Recruiting
-
- participants needed
- 900
-
- sponsor
- Sanofi
Summary
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 |
|---|---|
| Age | 18years - 55years |
| Treatment | SAR442168, Placebo to match SAR442168, Teriflunomide HMR1726, Placebo to match Teriflunomide |
| Clinical Study Identifier | NCT04410991 |
| Sponsor | Sanofi |
| Last Modified on | 14 August 2023 |
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