Tolebrutinib
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
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
CompletedNCT05282030
Start: 2022-03-10End: 2022-08-02Updated: 2025-02-06
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
CompletedNCT05283915
Start: 2022-03-18End: 2022-05-24Updated: 2025-01-15
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
CompletedNCT06064539
Start: 2020-05-18End: 2020-07-08Updated: 2025-09-17
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
CompletedNCT06106074
Start: 2020-08-10End: 2022-05-23Updated: 2023-10-30
Phase 2
Phase 3
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
CompletedNCT04410978
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
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
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
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
Target: 75Updated: 2023-11-27
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Active, not recruitingNCT06372145
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
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
Start: 2020-11-04End: 2025-11-14Target: 487Updated: 2025-12-17