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

Inclusion Criteria:

The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:

Group A (RMS)

• The participant must be 18 to 55 years of age, inclusive, at the time of signing theinformed consent.

• The participant must have been diagnosed with RMS in accordance with the 2017revised McDonald criteria.

• The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5at 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. GroupB (nrSPMS)

• Participant must have a previous diagnosis of RRMS in accordance with the 2017revised McDonald criteria

• The participant must be 18 to 60 years of age, inclusive, at the time of signing theinformed consent.

• The participant must have a current diagnosis of SPMS in accordance with theclinical course criteria revised in 2013.

• The participant must have documented evidence of disability progression observedduring 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, atthe 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.

Exclusion Criteria:

• The participant has been diagnosed with primary progressive MS according to the 2017revision of the McDonald diagnostic criteria.

• The participant has a history of infection or may be at risk for infection:

• Fever within 28 days of the Screening Visit

• 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 antiphospholipid syndrome and anyparticipants requiring antithrombotic treatment.

• Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN atscreening or a history of primary hypogammaglobulinemia.

• A history or presence of disease that can mimic MS symptoms.

• The participant has a contraindication for MRI.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.