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

NCT04410978 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 974

Last updated 2025-07-02

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2024-07-15
Completion
2024-07-15
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04410978 on ClinicalTrials.gov