Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Sponsor: Zenas BioPharma (USA), LLC
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.
Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2026-03
Completion Date
2030-07
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
Orelabrutinib orally
Placebo
Placebo orally
Locations (1)
Neurology Associates
Maitland, Florida, United States