A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
NCT07225504 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1275
Last updated 2026-05-19
Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Conditions
- Secondary Progressive Multiple Sclerosis (SPMS)
Interventions
- DRUG
-
Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
- DRUG
-
Matching placebo (binded), oral tablet
- DRUG
-
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-11
- Primary Completion
- 2030-12-03
- Completion
- 2034-01-02
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Bulgaria
- Canada
- China
- Colombia
- Czechia
- Denmark
- Estonia
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- South Africa
- Spain
- Switzerland
- United Kingdom
Study Locations
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