# Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

> **NCT04410991** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 899 (actual)

## Conditions studied

- Relapsing Multiple Sclerosis

## Interventions

- **DRUG:** Tolebrutinib
- **DRUG:** Teriflunomide HMR1726
- **DRUG:** Placebo to match Tolebrutinib
- **DRUG:** Placebo to match Teriflunomide

## Key facts

- **NCT ID:** NCT04410991
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-06-11
- **Primary completion:** 2024-07-16
- **Final completion:** 2024-07-16
- **Target enrollment:** 899 (ACTUAL)
- **Last updated:** 2025-07-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04410991

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04410991, "Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT04410991. Licensed CC0.

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