Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
NCT04458051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 767
Last updated 2026-01-07
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
Conditions
Interventions
- DRUG
-
Tolebrutinib
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
- DRUG
-
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-13
- Primary Completion
- 2025-11-14
- Completion
- 2025-11-14
- FDA Drug
- Yes
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
Study Locations
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