Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Primary Progressive Multiple Sclerosis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study.
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study.
Tracking Information
- NCT #
- NCT04458051
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi