Orelabrutinib for non-active secondary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Orelabrutinib is a brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor being tested in people with non-active secondary progressive multiple sclerosis (SPMS). This phase 3, randomized, double-blind, parallel-group, multicenter trial will enroll about 990 adults and randomize them 2:1 to once-daily orelabrutinib or placebo for a treatment period that ranges from roughly 24 to 60 months, with a minimum of 12 months required for the primary analysis. Participants will be screened up to four weeks, undergo regular clinical and safety assessments, and those with 24-week confirmed disability progression by EDSS may enter a two-year open-label orelabrutinib extension, with a four-week safety follow-up after treatment discontinuation. The primary focus is on whether orelabrutinib can slow disability progression in people with non-active SPMS who have been relapse-free for at least 24 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 to 60 years of age, inclusive, at the time of signing the informed consent.
2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
4. 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).
5. Absence of clinical relapses for at least 24 months.

Exclusion Criteria:

1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
3. History or current diagnosis of other neurological disorders that may mimic MS
4. History or current diagnosis of progressive multifocal leukoencephalopathy
5. Active, clinically significant viral, bacterial, or fungal infection
6. History of any other significant active medical condition
7. History of suicidal behavior within 6 months prior to Screening
8. Any prior history of malignancy
9. Patients on anticoagulation, or antiplatelet therapy
10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
11. Clinically significant laboratory abnormalities at Screening.
12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Where it's running

• Arizona Neuroscience Research, LLC
  Phoenix, Arizona, United States Recruiting
• Perseverance Research Center, LLC (PRC)
  Scottsdale, Arizona, United States Recruiting
• Fullerton Neurology and Headache Center
  Fullerton, California, United States Recruiting
• Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))
  Torrance, California, United States Recruiting
• Regina Berkovich MD, PhD Inc
  West Hollywood, California, United States Recruiting
• SFM Clinical Research, LLC
  Boca Raton, Florida, United States Recruiting

+40 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Patient and Medical Information
• Email: clinicaltrialsinfo@zenasbio.com
• Phone: 833-269-4696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.