A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Recruiting now Phase 3 NCT07299019
Run by Zenas BioPharma (USA), LLC · for 18 to 60 · All sexes
What this study 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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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
- History of suicidal behavior within 6 months prior to Screening
- Any prior history of malignancy
- Patients on anticoagulation, or antiplatelet therapy
- Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
- Clinically significant laboratory abnormalities at Screening.
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
- History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.
Where this trial is running
- Arizona Neuroscience Research, LLC, Phoenix, Arizona, United States
- Perseverance Research Center, LLC (PRC), Scottsdale, Arizona, United States
- Fullerton Neurology and Headache Center, Fullerton, California, United States
- Regina Berkovich MD, PhD Inc, West Hollywood, California, United States
- Nova Clinical Research, LLC, Bradenton, Florida, United States
- Neurology Associates, Maitland, Florida, United States
- KC Research Center, PA Neurology Research Dept, Roeland Park, Kansas, United States
- Boston Clinical Trials, Boston, Massachusetts, United States
- Profound Research LLC at Oakland Neurology Center, Rochester Hills, Michigan, United States
- Washington University School of Medicine, St Louis, Missouri, United States
- The Boster Center for Multiple Sclerosis, Columbus, Ohio, United States
- Lone Star Neurology, San Antonio, Texas, United States
+ 1 more sites.
Who to contact
Patient and Medical Information · 833-269-4696 · clinicaltrialsinfo@zenasbio.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07299019.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.