A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

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.

Eligibility

Age range: 18–60 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening. Exclusion Criteria: * Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) * Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticoste…

Locations (65)

Arizona Neuroscience Research, LLC
Pheonix, Arizona
Perseverance Research Center
Scottsdale, Arizona
Regina Berkovich MD, PhD Inc.
West Hollywood, California
Nova Clinical Research, LLC
Bradenton, Florida
Neurology Associates, PA
Maitland, Florida
University of South Florida Department of Neurology - MS Division
Tampa, Florida

Summary

Eligibility

Interventions

Locations (65)