Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
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- STATUS
- Recruiting
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- End date
- Sep 6, 2023
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- participants needed
- 900
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- 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 population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety 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 | NCT04410978 |
| Sponsor | Sanofi |
| Last Modified on | 24 May 2022 |
Eligibility
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