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

Official Summary

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 or 11 for participants receiving frexalimab SC or IV, respectively, 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 160 participants

Interventions

• DRUG: Frexalimab — Pharmaceutical form:Solution for injection-Route of administration:SC injection
• DRUG: Frexalimab — Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
• DRUG: MRI contrast-enhancing preparations — Route of administration:IV injection

Primary Outcomes

• Area under the curve over the interval W20 to W24(part A) (Until Week 24)
• Trough concentration at steady state(part A) (Until Week 24)

Secondary Outcomes

• Frexalimab plasma concentrations over time(part A) (Until Week 24)
• Pharmacokinetic parameters: Cmax(part A) (Until Week 24)
• Pharmacokinetic parameters: Tmax(part A) (Until Week 24)
• 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 (Until Week 96)
• Incidence of ADAs over time(part A) (Until Week 96)

Trial Locations

• North Central Neurology Associates- Site Number : 8401100, Cullman, Alabama, United States
• Alabama Neurology Associates- Site Number : 8400115, Homewood, Alabama, United States
• Perseverance Research Center- Site Number : 8400138, Scottsdale, Arizona, United States
• Private Practice - Dr. Regina Berkovich- Site Number : 8400005, West Hollywood, California, United States
• Neurology of Central Florida- Site Number : 8400147, Altamonte Springs, Florida, United States
• Aqualane Clinical Research- Site Number : 8400026, Naples, Florida, United States
• Neurology Associates of Ormond Beach- Site Number : 8400086, Ormond Beach, Florida, United States
• Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002, Charlotte, North Carolina, United States
• Raleigh Neurology Associates- Site Number : 8400014, Raleigh, North Carolina, United States
• Hope Neurology- Site Number : 8400019, Knoxville, Tennessee, United States

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