Dayton Center for Neurological Disorders | Centerville, OH
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About
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:
Enrollment
Sex
Ages
Volunteers
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:
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 above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
1,400 participants in 2 patient groups
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Central trial contact
Trial Transparency email recommended (Toll free number for US & Canada)
Data sourced from clinicaltrials.gov
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