Tolebrutinib
- Generic Name
- Tolebrutinib
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
- Conditions
- Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis
- Interventions
- First Posted Date
- 2024-04-17
- Last Posted Date
- 2025-03-07
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 2500
- Registration Number
- NCT06372145
- Locations
- 🇨🇿
Investigational Site Number : 2030008, Prague, Czechia
🇨🇿Investigational Site Number : 2039906, Prague, Czechia
🇨🇿Investigational Site Number : 2039905, Prague, Czechia
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
- First Posted Date
- 2023-10-30
- Last Posted Date
- 2023-10-30
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 71
- Registration Number
- NCT06106074
- Locations
- 🇺🇸
New Orleans Clinical Research Site Number : 8400001, Knoxville, Tennessee, United States
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
- Conditions
- Multiple Sclerosis
- Interventions
- First Posted Date
- 2023-10-03
- Last Posted Date
- 2023-10-03
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 30
- Registration Number
- NCT06064539
- Locations
- 🇺🇸
Prism Research-Site Number:8400001, Saint Paul, Minnesota, United States
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
- First Posted Date
- 2022-03-17
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 10
- Registration Number
- NCT05283915
- Locations
- 🇺🇸
Clinical Pharmacology of Miami Site Number : 8400002, Miami, Florida, United States
🇺🇸Nucleus Network Site Number : 8400001, Saint Paul, Minnesota, United States
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
- First Posted Date
- 2022-03-16
- Last Posted Date
- 2025-02-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 22
- Registration Number
- NCT05282030
- Locations
- 🇺🇸
Clinical Pharmacology of Miami Site Number : 8400002, Miami, Florida, United States
🇺🇸Nucleus Network Site Number : 8400001, Saint Paul, Minnesota, United States
🇺🇸Volunteer Research Group-NOCCR Site Number : 8400003, Knoxville, Tennessee, United States
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
- Conditions
- Primary Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-07-07
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 767
- Registration Number
- NCT04458051
- Locations
- 🇺🇸
Multiple Sclerosis Center- Site Number : 8400143, Los Angeles, California, United States
🇺🇸University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137, San Francisco, California, United States
🇺🇸Neurology Associates, PA- Site Number : 8400004, Maitland, Florida, United States
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
- Conditions
- Secondary Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo to match Tolebrutinib
- First Posted Date
- 2020-06-02
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 1131
- Registration Number
- NCT04411641
- Locations
- 🇺🇸
University of Alabama MS Center-Site Number:8400013, Birmingham, Alabama, United States
🇺🇸Center for Neurology and Spine-Site Number:8400089, Phoenix, Arizona, United States
🇺🇸Arcadia Neurology Center-Site Number:8400070, Arcadia, California, United States
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Drug: Placebo to match Tolebrutinib
- First Posted Date
- 2020-06-01
- Last Posted Date
- 2024-04-19
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 900
- Registration Number
- NCT04410991
- Locations
- 🇺🇸
CHI Saint Joseph Medical Group Neurology-Site Number:8400110, Lexington, Kentucky, United States
🇮🇳Investigational Site Number :3560005, Chandigarh, India
🇷🇺Investigational Site Number :6430007, Moscow, Russian Federation
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Drug: Placebo to match Tolebrutinib
- First Posted Date
- 2020-06-01
- Last Posted Date
- 2024-04-19
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 900
- Registration Number
- NCT04410978
- Locations
- 🇺🇸
University of Texas Southwestern Medical Center-Site Number:8400077, Dallas, Texas, United States
🇺🇸Meridian Clinical Research-Site Number:8400003, Savannah, Georgia, United States
🇧🇬Investigational Site Number :1000001, Sofia, Bulgaria
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
- First Posted Date
- 2019-11-20
- Last Posted Date
- 2022-04-25
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 6
- Registration Number
- NCT04171310
- Locations
- 🇬🇧
Investigational Site Number 8260001, Nottingham, United Kingdom
Drug Development Updates
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