Trials / Completed
CompletedNCT04410991
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 899 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Study duration varied per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study were offered to participate in a long term safety study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolebrutinib | Pharmaceutical form: Tablet Route of administration: Oral |
| DRUG | Teriflunomide HMR1726 | Pharmaceutical form: Tablet Route of administration: Oral |
| DRUG | Placebo to match Tolebrutinib | Pharmaceutical form: Tablet Route of administration: Oral |
| DRUG | Placebo to match Teriflunomide | Pharmaceutical form: Tablet Route of administration: Oral |
Timeline
- Start date
- 2020-06-11
- Primary completion
- 2024-07-16
- Completion
- 2024-07-16
- First posted
- 2020-06-01
- Last updated
- 2025-07-02
- Results posted
- 2025-06-18
Locations
186 sites across 28 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Latvia, Netherlands, Norway, Portugal, Puerto Rico, Russia, Serbia, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04410991. Inclusion in this directory is not an endorsement.