clinical trial · NCT07067463
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Zenas BioPharma (USA), LLC·phase3·recruiting·n = 705
Multiple Sclerosis (MS) Primary ProgressiveOrelabrutinibPlacebo
brief 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.
started
Mar 23, 2026
primary completion
Jun 1, 2030
completion
Jul 1, 2030
last updated
May 18, 2026
official title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol