Actively Recruiting
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Led by Zenas BioPharma (USA), LLC · Updated on 2025-12-04
705
Participants Needed
2
Research Sites
239 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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
CONDITIONS
Official Title
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, inclusive
- Diagnosed with Primary Progressive Multiple Sclerosis (PPMS) according to 2017 McDonald criteria
- Documented evidence of disability progression during the 24 months before screening
- Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5 points, inclusive at screening
You will not qualify if you...
- Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- Presence of immunologic disorders other than MS or conditions requiring corticosteroid therapy
- History or current diagnosis of neurological disorders that may mimic MS
- History of any other significant active medical condition
- History of suicidal behavior within 6 months prior to screening
- Any prior history of malignancy without recurrence within 5 years
- Current use of anticoagulation or antiplatelet therapy
- Use of strong/moderate CYP3A inhibitors or inducers within 14 days before screening
- Clinically significant laboratory abnormalities at screening
- Allergy, contraindication, or intolerance to orelabrutinib or its excipients
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to screening
- History of alcohol abuse, alcohol use disorder, or other drug abuse within 12 months prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Neurology Associates, PA
Maitland, Florida, United States, 32751
Actively Recruiting
2
Premier Neurology
Greenville, South Carolina, United States, 29605
Actively Recruiting
Research Team
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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