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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

2026-03-23

Completion Date

2030-07

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib orally

DRUG

Placebo

Placebo orally

Locations (8)

Perseverance Research Center, LLC (PRC)

Scottsdale, Arizona, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Neurology Associates

Maitland, Florida, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Profound Research LLC at Oakland Neurology Center

Rochester Hills, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Lone Star Neurology

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman

Sherman, Texas, United States