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Phase 3Recruiting

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Sponsored by Zenas BioPharma (USA), LLC

About this study

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.

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 naSPMS. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally. The study consists of the following periods: * Screening Period: Up to 4 weeks. * Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment. A month is defined as a period of 28 days by convention. * Double-blinded (DB) Treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period. The study will be unblinded when all participan…

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.