Actively Recruiting
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Led by Zenas BioPharma (USA), LLC · Updated on 2026-05-06
990
Participants Needed
5
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years inclusive at consent
- Previous diagnosis of relapsing-remitting MS according to 2024 McDonald criteria
- Current diagnosis of secondary progressive MS according to 2013 clinical course criteria
- Documented disability progression independent of relapse in the 24 months before screening
- No clinical relapses for at least 24 months
You will not qualify if you...
- Diagnosis of primary progressive MS according to 2024 McDonald criteria
- Other immunologic disorders requiring corticosteroids
- History or current diagnosis of neurological disorders mimicking MS
- History or current progressive multifocal leukoencephalopathy
- Active significant viral, bacterial, or fungal infection
- Other significant active medical conditions
- History of suicidal behavior within 6 months prior to screening
- Any prior history of malignancy
- Use of anticoagulation or antiplatelet therapy
- Use of strong/moderate CYP3A inhibitors or inducers within 14 days
- Clinically significant lab abnormalities at screening
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to screening
- History of alcohol or drug abuse within 12 months prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Perseverance Research Center, LLC (PRC)
Scottsdale, Arizona, United States, 85253
Actively Recruiting
2
Neurology Associates
Maitland, Florida, United States, 32751
Actively Recruiting
3
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Actively Recruiting
4
Lone Star Neurology
San Antonio, Texas, United States, 78258
Actively Recruiting
5
Texas Institute for Neurological Disorders - Sherman
Sherman, Texas, United States, 75092
Actively Recruiting
Research Team
P
Patient and Medical Information
CONTACT
P
Patient and Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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