This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.
The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.
The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
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).
1 documented relapse within the previous year OR
The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
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 any participants requiring antithrombotic treatment.
Parallel
Frexalimab
DrugPharmaceutical form:Solution for injection-Route of administration:SC injection
Frexalimab
DrugPharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
MRI contrast-enhancing preparations
DrugRoute of administration:IV injection
Area under the curve over the interval W20 to W24(part A)
AUCW20-W24
Trough concentration at steady state(part A)
Ctrough,SS
Frexalimab plasma concentrations over time (part A for IV Arm Part A, B, C for SC arm)
Pharmacokinetic parameters: Cmax(part A)
Pharmacokinetic parameters: Tmax(part A)
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period
