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Frexalimab

DRUG13 trials

Sponsors

Sanofi-Aventis Recherche & Developpement, Sanofi

Conditions

Focal Segmental GlomerulosclerosisGlomerulonephritis Minimal LesionImmune system diseasesKidney Transplant RejectionMultiple SclerosisMultiple sclerosisSystemic lupus erythematosusType 1 Diabetes Mellitus

Phase 2

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
RecruitingNCT06111586
SanofiType 1 Diabetes Mellitus
Start: 2023-12-11End: 2030-10-29Target: 192Updated: 2026-02-18
A 52-week randomized, double-blind, placebo-controlled, multi-center Phase 2b study with a 52-week blinded extension and an optional open-label extension—assessing the safety and efficacy of frexalimab, a CD40L-antagonist monoclonal antibody, for the preservation of pancreatic β-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy
RecruitingCTIS2022-500531-36-00
Sanofi-Aventis Recherche & DeveloppementType 1 diabetes mellitus
Start: 2024-02-02Target: 192Updated: 2026-01-09
Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study.
RecruitingCTIS2023-508654-26-00
Sanofi-Aventis Recherche & DeveloppementSystemic lupus erythematosus
Start: 2022-03-15Target: 44Updated: 2025-12-15
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
RecruitingNCT06500702
SanofiFocal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Start: 2024-12-19End: 2028-02-16Target: 84Updated: 2026-03-20
A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis.
Active, not recruitingCTIS2024-513527-17-00
Sanofi-Aventis Recherche & DeveloppementMultiple Sclerosis
Start: 2021-06-07Target: 72Updated: 2025-07-31
A parallel-group treatment, Phase 2a, multicenter, randomized, double-blind, placebo-controlled umbrella study to evaluate the efficacy and safety of frexalimab, brivekimig and rilzabrutinib in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
RecruitingCTIS2024-511775-15-00
Sanofi-Aventis Recherche & DeveloppementImmune system diseases
Start: 2025-01-17Target: 40Updated: 2025-12-15
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
RecruitingNCT07412470
SanofiKidney Transplant Rejection
Start: 2026-03-13End: 2033-08-15Target: 526Updated: 2026-03-27

Phase 3

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
RecruitingNCT06141473
SanofiMultiple Sclerosis
Start: 2023-12-13End: 2027-05-06Target: 1600Updated: 2026-03-05
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
RecruitingNCT06141486
SanofiMultiple Sclerosis
Start: 2023-12-27End: 2028-03-24Target: 900Updated: 2026-02-23
Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis
RecruitingCTIS2023-504358-36-00
Sanofi-Aventis Recherche & Developpementmultiple sclerosis
Start: 2024-10-17Target: 386Updated: 2026-01-10
Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis
RecruitingCTIS2024-514343-29-00
Sanofi-Aventis Recherche & Developpementmultiple sclerosis
Start: 2024-11-19Target: 410Updated: 2026-01-10
A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis
RecruitingCTIS2023-504359-29-01
Sanofi-Aventis Recherche & DeveloppementMultiple sclerosis
Start: 2024-12-11Target: 591Updated: 2026-01-12
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
RecruitingNCT07325292
SanofiMultiple Sclerosis
Start: 2026-01-14End: 2028-11-30Target: 160Updated: 2026-03-23

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