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A Study of Orelabrutinib in Patients With Primary 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 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.
Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
705
Start Date
2025-12
Completion Date
2030-07
Last Updated
2025-12-04
Healthy Volunteers
No
Interventions
Orelabrutinib
Orally
Placebo
Orally
Locations (2)
Neurology Associates, PA
Maitland, Florida, United States
Premier Neurology
Greenville, South Carolina, United States