Trials / Completed
CompletedNCT04458051
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 767 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Detailed description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolebrutinib | Pharmaceutical form: Film-coated Tablet Route of administration: Oral |
| DRUG | Placebo | Pharmaceutical form: Film-coated Tablet Route of administration: Oral |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2025-11-14
- Completion
- 2025-11-14
- First posted
- 2020-07-07
- Last updated
- 2026-01-07
Locations
277 sites across 42 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russia, Serbia, South Africa, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04458051. Inclusion in this directory is not an endorsement.