Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (FREXALT)
Investigating an Investigational Medication for Relapsing Multiple Sclerosis (RMS)
Brief description of study
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
- This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
- The study intervention duration will vary ranging from approximately 12 to 40 months.
- The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Sclerosis
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Age: 18 years - 55 years
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Gender: All
Inclusion Criteria:
- The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
- The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
The participant must have at least 1 of the following prior to screening:
- ≥1 documented relapse within the previous year OR
- ≥2 documented relapses within the previous 2 years, OR
- ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
- The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
- The participant has a history of infection or may be at risk for infection:
- The presence of psychiatric disturbance or substance abuse.
- 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.
- History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
- A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
- The participant has had a relapse in the 30 days prior to randomization.
- The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
This study investigates the effects of an investigational medication on individuals with Relapsing Multiple Sclerosis (RMS). RMS is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. The study aims to explore how the investigational treatment may impact these symptoms and the progression of the disease.
Participants in this study will undergo various procedures, including MRI scans to monitor brain activity and assess the presence of lesions. The study will also involve regular assessments of neurological function and overall health to evaluate the effects of the investigational medication.
- Who can participate: Adults diagnosed with Relapsing Multiple Sclerosis (RMS) who have had at least one relapse in the past year or two relapses in the past two years, or have a lesion on an MRI scan. Participants should have an EDSS score of 5.5 or lower.
- Study details: Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve regular health assessments and MRI scans to monitor the effects of the treatment.
