A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary 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 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.
Description
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 naSPMS. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally. The study consists of the following periods: * Screening Period: Up to 4 weeks. * Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment. A month is defined as a period of 28 days by convention. * Double…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the S…
Interventions
- DrugOrelabrutinib
Orelabrutinib orally
- DrugPlacebo
Placebo orally
Locations (5)
- Perseverance Research Center, LLC (PRC)Scottsdale, Arizona
- Neurology AssociatesMaitland, Florida
- Boston Clinical TrialsBoston, Massachusetts
- Lone Star NeurologySan Antonio, Texas
- Texas Institute for Neurological Disorders - ShermanSherman, Texas