Actively Recruiting
A Phase 3, Randomized, Double-blind Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
Led by Zenas BioPharma (USA), LLC · Updated on 2026-06-05
990
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of orelabrutinib, a brain-penetrating BTK inhibitor, compared to placebo in patients with non-active Secondary Progressive Multiple Sclerosis (SPMS). This phase 3, randomized, double-blind, parallel-group, multicenter study aims to enroll approximately 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. The study is sponsored by Zenas BioPharma (USA), LLC and will investigate how orelabrutinib affects disability progression in this population. Participants will be randomly assigned in a 2:1 ratio to receive either oral orelabrutinib once daily or a matching placebo. The study includes several periods: up to 4 weeks for screening; a treatment period lasting approximately 24 to 60 months depending on enrollment timing; a double-blind treatment phase with a minimum of 12 months; and an open-label treatment phase of up to 2 years for eligible participants experiencing disability progression. After treatment, a 4-week safety follow-up will occur for those who discontinue early or do not enter the long-term safety study. During the study, participants will undergo assessments to monitor disability progression confirmed over 24 weeks, along with other functional and imaging tests such as MRI lesions and various physical and cognitive performance measures. Researchers will also evaluate safety and tolerability throughout the trial. All participants will have a final study visit near the end date, and ongoing treatment with orelabrutinib may continue for those entering the long-term safety phase. The total participation time varies but includes extensive monitoring over several years.
CONDITIONS
Brief Title
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 60 years of age, inclusive, at the time of signing the informed consent
- Previous diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to 2024 McDonald criteria
- Current diagnosis of secondary progressive multiple sclerosis (SPMS) according to 2013 clinical course criteria
- Documented evidence of disability progression independent of clinical relapse within 24 months before screening
- No clinical relapses for at least 24 months prior to screening
You will not qualify if you...
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to 2024 McDonald criteria
- Immunologic disorders other than MS or conditions requiring corticosteroid therapy
- Other neurological disorders that may mimic MS
- History or diagnosis of progressive multifocal leukoencephalopathy
- Active significant viral, bacterial, or fungal infection
- Any other significant active medical condition
- Suicidal behavior within 6 months prior to screening
- Prior history of malignancy
- Use of anticoagulant or antiplatelet therapy
- Use of strong or moderate CYP3A inhibitors or inducers within 14 days prior to screening
- Clinically significant laboratory 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 to 60 months, depending on time of recruitment
Participants receive daily oral treatment with either orelabrutinib or placebo during the double-blind treatment period.
Regular visits during treatment period as per study schedule
Duration - Up to 2 years
Participants with confirmed disability progression at 24 weeks may continue with open-label orelabrutinib treatment for up to 2 years.
Visits according to open-label treatment schedule
Duration - 4 weeks
Participants who discontinue treatment early or complete the trial but do not enter the long-term safety study have a safety follow-up to monitor health.
1 visit (in-person)
Trial Site Locations
Total: 12 locations
1
Arizona Neuroscience Research, LLC
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
Perseverance Research Center, LLC (PRC)
Scottsdale, Arizona, United States, 85253
Actively Recruiting
3
Fullerton Neurology and Headache Center
Fullerton, California, United States, 92835
Actively Recruiting
4
Regina Berkovich MD, PhD Inc
West Hollywood, California, United States, 90048
Actively Recruiting
5
Nova Clinical Research, LLC
Bradenton, Florida, United States, 34209
Actively Recruiting
6
Neurology Associates
Maitland, Florida, United States, 32751
Actively Recruiting
7
KC Research Center, PA Neurology Research Dept
Roeland Park, Kansas, United States, 66205
Actively Recruiting
8
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Withdrawn
9
Profound Research LLC at Oakland Neurology Center
Rochester Hills, Michigan, United States, 48307
Actively Recruiting
10
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Lone Star Neurology
San Antonio, Texas, United States, 78258
Actively Recruiting
12
Texas Institute for Neurological Disorders - Sherman
Sherman, Texas, United States, 75092
Actively Recruiting
Research Team
P
Patient and Medical Information
P
Patient and Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here