Clinical Trial

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 20 -> 23 locations 2026-07-31
notable Trial sites expanded: 13 -> 18 locations 2026-07-19
notable Trial sites expanded: 9 -> 12 locations 2026-06-06
notable Trial sites expanded: 5 -> 8 locations 2026-05-20
notable Trial sites expanded: 1 -> 5 locations 2026-05-07
Trial Details
NCT Number NCT07299019
Lead Sponsor Zenas BioPharma (USA), LLC
Conditions Secondary Progressive Multiple Sclerosis
Enrollment 990 participants
Start Date 2026-03-23
Primary Completion 2030-06 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13