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โ† Trials
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A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

RecruitingPhase 3Ages 18 Years - 60 YearsAllZenas BioPharma (USA), LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Orelabrutinib
  • Placebo
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Where

61 sites
Arizona Neuroscience Research, LLC
Phoenix, United States
Perseverance Research Center, LLC (PRC)
Scottsdale, United States
Fullerton Neurology and Headache Center
Fullerton, United States
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))
Torrance, United States
Regina Berkovich MD, PhD Inc
West Hollywood, United States
SFM Clinical Research, LLC
Boca Raton, United States
Nova Clinical Research, LLC
Bradenton, United States
MS and Neuromuscular Center of Excellence
Clearwater, United States

โ€ฆand 53 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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