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RECRUITING
NCT07067463
PHASE3

A Study of Orelabrutinib in Patients With Primary 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 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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

705

Start Date

2026-03-23

Completion Date

2030-07

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orally

DRUG

Placebo

Orally

Locations (11)

Arizona Neuroscience Research, LLC

Pheonix, Arizona, United States

Perseverance Research Center

Scottsdale, Arizona, United States

Regina Berkovich MD, PhD Inc.

West Hollywood, California, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Neurology Associates, PA

Maitland, Florida, United States

Washington University School of Medicine

St Louis, Missouri, United States

Velocity Clinical Research, Raleigh Neurology

Raleigh, North Carolina, United States

Premier Neurology

Greenville, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Lone Star Neurology

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States