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Showing 1–12 of 12 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Tolebrutinib Clear all
Active, not recruiting Phase 3 Interventional

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

NCT06372145
View directory record Official record
Conditions
Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
Interventions
Tolebrutinib, Placebo, Teriflunomide
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
2,500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
52
States / cities
Birmingham, Alabama • Cullman, Alabama • Phoenix, Arizona + 47 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 2, 2026, 4:27 PM EDT
Not listed Phase 2 Interventional Results available

Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

NCT04742400
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
tolebrutinib 60mg, tolebrutinib 120mg
Drug
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
18 Years to 120 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 12, 2024 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

NCT06106074
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
Tolebrutinib, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 45 Years
Enrollment
71 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2022
U.S. locations
1
States / cities
Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Oct 29, 2023 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 1 Interventional

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

NCT05283915
View directory record Official record
Conditions
Hepatic Function Abnormal
Interventions
tolebrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 79 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
2
States / cities
Miami, Florida • Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Jan 14, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 3 Interventional

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

NCT04458051
View directory record Official record
Conditions
Primary Progressive Multiple Sclerosis
Interventions
Tolebrutinib, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
767 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
45
States / cities
La Jolla, California • Los Alamitos, California • Los Angeles, California + 41 more
Source: ClinicalTrials.gov public record
Updated Jan 6, 2026 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 1 Interventional

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.

NCT05282030
View directory record Official record
Conditions
Renal Impairment
Interventions
tolebrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 79 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
3
States / cities
Miami, Florida • Saint Paul, Minnesota • Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 2 Interventional Results available

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

NCT03996291
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Tolebrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
8
States / cities
Cullman, Alabama • Maitland, Florida • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

NCT05132569
View directory record Official record
Conditions
Myasthenia Gravis
Interventions
Tolebrutininb, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 85 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
5
States / cities
Washington D.C., District of Columbia • Boca Raton, Florida • Tampa, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 3 Interventional Results available

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

NCT04410978
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Tolebrutinib, Teriflunomide, Placebo to match Tolebrutinib, Placebo to match Teriflunomide
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
974 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
23
States / cities
Birmingham, Alabama • San Francisco, California • Aurora, Colorado + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 3 Interventional Results available

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

NCT04411641
View directory record Official record
Conditions
Non-relapsing Secondary Progressive Multiple Sclerosis
Interventions
Tolebrutinib, Placebo to match Tolebrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 60 Years
Enrollment
1,131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
51
States / cities
Birmingham, Alabama • Phoenix, Arizona • Arcadia, California + 44 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

NCT06064539
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
Tolebrutinib, gemfibrozil, rifampicin
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 45 Years · Male only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 16, 2025 · Synced Sep 2, 2026, 4:27 PM EDT
Completed Phase 3 Interventional Results available

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

NCT04410991
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Tolebrutinib, Teriflunomide HMR1726, Placebo to match Tolebrutinib, Placebo to match Teriflunomide
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
899 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
43
States / cities
Cullman, Alabama • Phoenix, Arizona • Arcadia, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2025 · Synced Sep 2, 2026, 4:27 PM EDT