Phase 3Recruiting
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
- Sponsor
- Zenas BioPharma (USA), LLC (Industry)
- Enrolment
- 705 planned
- Conditions
- Multiple Sclerosis (MS) Primary Progressive
- Interventions
- Orelabrutinib; Placebo
- Ages
- adults
- Registry
- NCT07067463
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered