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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Multiple Sclerosis (MS) Primary Progressive

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 60 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Zenas BioPharma (USA), LLC

Last updated on ClinicalTrials.gov

October 13, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites