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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
2026-03-23
Completion Date
2030-07
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
Orelabrutinib orally
Placebo
Placebo orally
Locations (8)
Perseverance Research Center, LLC (PRC)
Scottsdale, Arizona, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
Neurology Associates
Maitland, Florida, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Profound Research LLC at Oakland Neurology Center
Rochester Hills, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Lone Star Neurology
San Antonio, Texas, United States
Texas Institute for Neurological Disorders - Sherman
Sherman, Texas, United States