A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis (NCT07299019) | Clinical Trial Compass
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
United States990 participantsStarted 2026-03-23
Plain-language summary
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 to 60 years of age, inclusive, at the time of signing the informed consent.
✓. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
✓. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
✓. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).
✓. Absence of clinical relapses for at least 24 months.
Exclusion criteria
✕. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
✕. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
✕. History or current diagnosis of other neurological disorders that may mimic MS
✕. History or current diagnosis of progressive multifocal leukoencephalopathy
✕. Active, clinically significant viral, bacterial, or fungal infection
✕. History of any other significant active medical condition
What they're measuring
1
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks