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Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

NCT03996291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-10-23

Study results available
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Summary

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Conditions

Interventions

DRUG

Tolebrutinib

Pharmaceutical form: Film coated tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2024-11-26
Completion
2024-11-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Estonia
  • France
  • Netherlands
  • Russia
  • Spain
  • 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 NCT03996291 on ClinicalTrials.gov