Status: Recruiting
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
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.
Participants needed: 990
Trial details
Phase: Phase 3Age: 18-60Biological sex: AllType: InterventionalSponsor: Zenas BioPharma (USA), LLCUpdated: Oct 7, 2026Locations: 52
Eligibility criteria
18 to 60 years of age, inclusive, at the time of signing the informed consent. [+4]
The patient has been diagnosed with primary progressive MS (PPMS) according to 2... [+12]