Clinical Trial

A Study of Orelabrutinib in Patients With Primary 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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Protocol Amendment History 3 changes
notable Trial sites expanded: 34 -> 40 locations 2026-07-29
notable Trial sites expanded: 27 -> 32 locations 2026-07-23
notable Trial sites expanded: 17 -> 21 locations 2026-07-08
Trial Details
NCT Number NCT07067463
Lead Sponsor Zenas BioPharma (USA), LLC
Conditions Multiple Sclerosis (MS) Primary Progressive
Enrollment 705 participants
Start Date 2026-03-23
Primary Completion 2030-06 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-07