Phase 3 Study of Subcutaneous vs Intravenous Frexalimab in Human MS Patients

study design"studyType": "INTERVENTIONAL"

subjects"facility": "The Boster Center for Multiple Sclerosis- Site Number : 8400006",

sample size"count": 160

sample size basis"type": "ESTIMATED"

randomized"allocation": "RANDOMIZED"

regulatory approval"isFdaRegulatedDrug": true

regulatory approval details"isFdaRegulatedDrug": true

relevant ms typesGroup B (nrSPMS)\n* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria\n* The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n* The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.\n* The participant must have documented evidence of disability progression observed during the 12 months before screening.\n* The participant must have an absence of clinical relapses for at least 24 months.\n* The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).\n\nParticipants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:\n\n\\- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.\n* The participant has a history of infection or may be at risk for infection:\n* Fever within 28 days of the Screening Visit\n* Presence of psychiatric disturbance or substance abuse\n* 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.\n* Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.\n* A history or presence of disease that can mimic MS symptoms.\n* The participant has a contraindication for MRI.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",

intervention"description": "Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)"

primary endpoint"measure": "Area under the curve over the interval W20 to W24(part A)"

follow upOptional 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.\n\nThe 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.

findings"officialTitle": "A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis",

limitationsPlanned enrolment and endpoints are not findings.