Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03889639

Run by

Sanofi

People needed

130

Starts

2019-03-29

Expected to finish

2020-01-02

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
• Participant was diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
• Participant must had at least 1 documented relapse within the previous year, OR greater than or equal to (>=) 2 documented relapses within the previous 2 years, OR >=1 active Gadolinium (Gd) enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
• A female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for >=12 months with serum follicle-stimulating hormone (FSH) level greater than (>) 30 International Units per liters.
• Male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
• Male participants whose partners were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
• Male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose.
• Participant had given written informed consent prior to undertaking any study-related procedure.

You may not qualify if…

• The participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis.
• Requirement for concomitant treatment that could bias the primary evaluation.
• Contraindication for MRI.
• Contraindications to use MRI Gd contrast-enhancing preparations.
• History of infection with the human immunodeficiency virus (HIV).
• History of active or latent tuberculosis.
• Any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the Investigator.
• Presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the Investigator's judgment to be clinically significant.
• Presence of liver injury.
• At screening, the participant was positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or was positive for hepatitis C antibody.
• Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
• Participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
• Participant was receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
• Participant was receiving anticoagulant/antiplatelet therapies.
• Participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit.
• Participant had an Expanded Disability Status Scale score >5.5 at first screening visit.
• Participant had a relapse in the 30 days prior to randomization.
• Participant was pregnant or a breastfeeding woman.
• History or presence of significant other concomitant illness.
• The participant had received medications/treatments for multiple sclerosis within a specified time frame.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400005 — Cullman, Alabama, United States
• Investigational Site Number 8400002 — Maitland, Florida, United States
• Investigational Site Number 8400004 — Sunrise, Florida, United States
• Investigational Site Number 8400009 — Tampa, Florida, United States
• Investigational Site Number 8400007 — Savannah, Georgia, United States
• Investigational Site Number 8400001 — Northbrook, Illinois, United States
• Investigational Site Number 8400008 — Dayton, Ohio, United States
• Investigational Site Number 8400006 — Westerville, Ohio, United States
• Investigational Site Number 8400003 — Knoxville, Tennessee, United States
• Investigational Site Number 1240002 — Gatineau, Canada
• Investigational Site Number 1240001 — Greenfield Park, Canada
• Investigational Site Number 1240003 — Vancouver, Canada
• Investigational Site Number 2030007 — Brno, Czechia
• Investigational Site Number 2030004 — Hradec Králové, Czechia
• Investigational Site Number 2030003 — Jihlava, Czechia
• Investigational Site Number 2030005 — Ostrava - Poruba, Czechia
• Investigational Site Number 2030006 — Pardubice, Czechia
• Investigational Site Number 2030001 — Prague, Czechia
• Investigational Site Number 2030002 — Praha 5 - Motol, Czechia
• Investigational Site Number 2330001 — Tallinn, Estonia
• Investigational Site Number 2500004 — Nancy, France
• Investigational Site Number 2500001 — Nantes, France
• Investigational Site Number 2500002 — Strasbourg, France
• Investigational Site Number 2500003 — Toulouse, France
• Investigational Site Number 5280001 — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.