Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

130

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach

9 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

March 1, 2019

Completed

25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed

3 days until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

March 8, 2023

Completed

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

March 1, 2019

Results QC Date

December 7, 2022

Last Update Submit

September 16, 2025

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions
Number of new Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants). Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to collected during placebo administration in Cohort 1 (Weeks 12 to 16).
After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants) and at Week 4 for Cohort 2 placebo

Secondary Outcomes (5)

Number of New or Enlarging T2 Lesions
After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placebo
Total Number of Gd-enhancing T1-hyperintense Lesions
After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placebo
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs): Weeks 1-4 Period
From Baseline up to Week 4
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events: SAR442168 Treatment Period
Weeks 1 to 12 for Cohort 1 participants and Weeks 4 to 16 for Cohort 2 participants
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
Baseline up to Week 12 for Cohort 1 participants; Baseline up to Week 4 for Cohort 2 Placebo and from Weeks 4 to 16 for Cohort 2 SAR442168 receiving participants

Study Arms (8)

Cohort 1: SAR442168 5 mg Then Placebo

EXPERIMENTAL

Participants received SAR442168 5 milligrams (mg), orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.