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Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

NCT03889639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-17

Study results available
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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.

Conditions

Interventions

DRUG

SAR442168

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

DRUG

Placebo

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

DRUG

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2020-01-02
Completion
2020-01-02
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Estonia
  • France
  • Netherlands
  • Russia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT03889639 on ClinicalTrials.gov