Status:
ACTIVE_NOT_RECRUITING
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 acti...
Detailed Description
The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2027
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04879628
Start Date
June 7 2021
End Date
August 23 2027
Last Update
September 30 2025
Active Locations (37)
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1
Center for Neurology and Spine- Site Number : 8400007
Phoenix, Arizona, United States, 85032
2
University of South Florida Site Number : 8400001
Tampa, Florida, United States, 33612
3
The Neurological Institute Site Number : 8400004
Charlotte, North Carolina, United States, 28204
4
Medical College of Wisconsin- Site Number : 8400006
Milwaukee, Wisconsin, United States, 53226