4 trials tracked · 4 active · last refreshed 2026-08-10
Frexalimab (Sanofi) targets CD40L, a different immune signaling pathway than the BTK inhibitors or B-cell-depleting antibodies tracked elsewhere here — it blocks communication between T cells and B cells rather than acting on either cell type directly, a mechanism not currently used by any approved MS drug. An earlier proof-of-concept trial reported it reduced new brain lesions on MRI markedly compared to placebo.
All 4 of its tracked trials are active and Phase II/III, testing it in both relapsing and non-relapsing secondary progressive MS, plus a formulation study comparing subcutaneous injection to IV infusion — the kind of practical delivery question that matters once a drug's core efficacy case looks strong enough to invest in convenience.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07325292 | Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | Phase III | Recruiting | 2026-01-14 |
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. Enrollment 160 (estimated) Sites 34 across 4 countries Countries Belgium, China, Japan, United States Sponsor Sanofi Primary outcome: Area under the curve over the interval W20 to W24(part A) | |||||
| ▸ | NCT06141486 | Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis | Phase III | Active, not recruiting | 2023-12-27 |
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months. Enrollment 943 (actual) Sites 311 across 27 countries Countries Argentina, Australia, Belgium, Brazil, Bulgaria +22 more Sponsor Sanofi Primary outcome: Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period | |||||
| ▸ | NCT06141473 | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | Phase III | Active, not recruiting | 2023-12-13 |
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed Enrollment 1,655 (actual) Sites 382 across 41 countries Countries Argentina, Austria, Belgium, Brazil, Bulgaria +36 more Sponsor Sanofi Primary outcome: Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses | |||||
| ▸ | NCT04879628 | Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis | Phase II | Active, not recruiting | 2021-06-07 |
Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To evaluate pharmacokinetics of SAR441344 Enrollment 129 (actual) Sites 37 across 10 countries Countries Bulgaria, Canada, Czechia, France, Germany +5 more Sponsor Sanofi Primary outcome: Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI) | |||||
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