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RECRUITING
NCT07299019
PHASE3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

990

Start Date

2026-03

Completion Date

2030-07

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib orally

DRUG

Placebo

Placebo orally

Locations (1)

Neurology Associates

Maitland, Florida, United States