Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Inclusion Criteria

• •Group A (RMS)
• •The 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 in accordance with the 2017 revised McDonald criteria.
• •The participant must have an Expanded Disability Status Scale (EDSS) score of ≤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. Group B (nrSPMS)
• •Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
• •The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
• •The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
• •The participant must have documented evidence of disability progression observed during the 12 months before screening.
• •The participant must have an absence of clinical relapses for at least 24 months.
• •The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).
• •Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:
• •\- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.