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Tolebrutinib

DRUG13 trials

Sponsors

Sanofi-Aventis Research & Development, Sanofi-Aventis Recherche & Developpement, Genzyme Corp., Sanofi

Conditions

Hepatic Function AbnormalMultiple SclerosisNervous system diseasesNon-relapsing Secondary Progressive Multiple SclerosisPrimary Progressive Multiple SclerosisProgressive Relapsing Multiple SclerosisRelapsing Multiple SclerosisRenal Impairment

Phase 1

Phase 2

Phase 3

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
CompletedNCT04410978
SanofiRelapsing Multiple Sclerosis
Start: 2020-06-30End: 2024-07-15Updated: 2025-07-02
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
CompletedNCT04410991
SanofiRelapsing Multiple Sclerosis
Start: 2020-06-11End: 2024-07-16Updated: 2025-07-02
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
CompletedNCT04411641
SanofiNon-relapsing Secondary Progressive Multiple Sclerosis
Start: 2020-09-24End: 2024-08-29Updated: 2025-07-02
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
CompletedNCT04458051
SanofiPrimary Progressive Multiple Sclerosis
Start: 2020-08-13End: 2025-11-14Updated: 2026-01-07
An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis
WithdrawnCTIS2023-503631-18-00
Sanofi-Aventis Research & DevelopmentNervous system diseases
Target: 75Updated: 2023-11-27
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Active, not recruitingNCT06372145
SanofiProgressive Relapsing Multiple Sclerosis, Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Start: 2024-04-16End: 2029-04-30Target: 2500Updated: 2026-02-13
An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis
Active, not recruitingCTIS2023-503631-18-01
Sanofi-Aventis Recherche & DeveloppementNervous system diseases
Start: 2024-05-20Target: 1405Updated: 2025-11-11
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
CompletedCTIS2024-514495-41-00
Genzyme Corp.Primary Progressive Multiple Sclerosis
Start: 2020-11-04End: 2025-11-14Target: 487Updated: 2025-12-17

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