NCT04410978

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

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: 974 (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 population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Detailed description

This was an event-driven (6-month confirmed disability worsening \[CDW\]) trial with a variable treatment duration (end-of-study \[EOS\] duration: up to approximately 48 months).

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Tolebrutinib	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Teriflunomide	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: 2020-06-30
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2020-06-01
• Last updated: 2025-07-02
• Results posted: 2025-06-18

Locations

179 sites across 24 countries: United States, Austria, Belarus, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, Germany, Hong Kong, Italy, Japan, Lithuania, Mexico, Poland, Romania, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study