Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Investigating the Effectiveness of an Investigational Medication in Slowing Disability Progression in nrSPMS
Study Overview
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 ranging from approximately 27 to 51 months.
- The study intervention duration will vary ranging from approximately 12 to 51 months.
- The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Sclerosis
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Age: Between 18 Years - 60 Years
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Gender: All
Inclusion Criteria:
- Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
- Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
- Absence of clinical relapses for at least 24 months.
- The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- The participant was previously exposed to frexalimab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the effectiveness of an investigational medication in slowing down the progression of disability in individuals with non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS). Secondary Progressive Multiple Sclerosis (SPMS) is a stage of multiple sclerosis where the disease worsens over time, with or without relapses. Participants in this study will either receive the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
Participants will undergo various study procedures, including regular visits to the study site. The study will involve monthly visits for the first six months, followed by visits every three months. Participants will be monitored for any changes in their condition and for any side effects of the investigational medication.
- Who can participate: Adults aged 18 to 60 years with a diagnosis of Secondary Progressive Multiple Sclerosis (SPMS) and a history of Relapsing-Remitting Multiple Sclerosis (RRMS) are eligible. Participants must have shown disability progression in the past year and have an EDSS score between 3.0 and 6.5. They must not have had clinical relapses for at least 24 months
- Study Details: Participants will receive either the investigational medication or a placebo. They will attend monthly visits for the first six months, then every three months. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine
- Study Visits: The study requires 27 visits
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