Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To evaluate pharmacokinetics of SAR441344

Key facts

Study ID

NCT04879628

Run by

Sanofi

People needed

129

Starts

2021-06-07

Expected to finish

2027-08-23

Last updated by the study team

2025-09-30

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.
• The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
• The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
• Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

You may not qualify if…

• The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
• The participant had conditions or situations that would adversely affect participation in this study.
• The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
• History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
• Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
• The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
• The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
• The participant had an EDSS score >5.5 at the first screening visit.
• The participant had a relapse in the 30 days prior to randomization.
• Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
• Abnormal laboratory test(s) at Screening.
• Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention.
• Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Center for Neurology and Spine- Site Number : 8400007 — Phoenix, Arizona, United States
• University of South Florida Site Number : 8400001 — Tampa, Florida, United States
• The Neurological Institute Site Number : 8400004 — Charlotte, North Carolina, United States
• Medical College of Wisconsin- Site Number : 8400006 — Milwaukee, Wisconsin, United States
• Investigational Site Number : 1000002 — Pleven, Bulgaria
• Investigational Site Number : 1000003 — Sofia, Bulgaria
• Investigational Site Number : 1000001 — Sofia, Bulgaria
• Investigational Site Number : 1240001 — Gatineau, Quebec, Canada
• Investigational Site Number : 2030003 — Brno, Czechia
• Investigational Site Number : 2030002 — Hradec Králové, Czechia
• Investigational Site Number : 2030001 — Jihlava, Czechia
• Investigational Site Number : 2030005 — Ostrava - Poruba, Czechia
• Investigational Site Number : 2030004 — Teplice, Czechia
• Investigational Site Number : 2500006 — Calais, France
• Investigational Site Number : 2760012 — Leipzig, Germany
• Investigational Site Number : 2760004 — Münster, Germany
• Investigational Site Number : 6430002 — Kazan', Russia
• Investigational Site Number : 6430007 — Moscow, Russia
• Investigational Site Number : 6430006 — Moscow, Russia
• Investigational Site Number : 6430001 — Moscow, Russia
• Investigational Site Number : 6430003 — Saint Petersburg, Russia
• Investigational Site Number : 6430005 — Saint Petersburg, Russia
• Investigational Site Number : 6430004 — Saint Petersburg, Russia
• Investigational Site Number : 6430008 — Tyumen, Russia
• Investigational Site Number : 7240004 — Barcelona, Barcelona [Barcelona], Spain

Full record on ClinicalTrials.gov

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