A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

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.

Timeline

Start

2026-03-23

Primary completion

2030-06

Completion

2030-07

Drugs

Indications