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

No results posted yet for this study

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

Placebo

Matching placebo (binded), oral tablet

DRUG

Remibrutinib (Open label)

Remibrutinib (Open Label), oral tablet

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225504 on ClinicalTrials.gov