CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
SAR442168 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03889639
NCT03889639Phase 2Completed
CompareCT.gov

A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis

Sanofi·interventional·Posted Mar 26, 2019·Updated Sep 17, 2025

In Brief

A Phase 2 clinical trial evaluating SAR442168, Placebo, and 1 other intervention for Relapsing Multiple Sclerosis. Completed, enrolled 130 participants across 48 sites in 10 countries.

Detailed Summary

Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: * To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. * To evaluate the safety and tolerability of SAR442168.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesCanada, Czechia, Estonia, France, Netherlands, Russia, Slovakia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartMar 29, 2019
Primary CompletionJan 2, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.3 years ago

Interventions

SAR442168drug

Pharmaceutical form: Film coated tablet; Route of administration: Oral

Placebodrug

Pharmaceutical form: Film coated tablet; Route of administration: Oral

Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)drug

Pharmaceutical form: Solution for injection; Route of administration: Intravenous