RecruitingPhase 3NCT07299019

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

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

Sponsor

Zenas BioPharma (USA), LLC

Enrollment

990 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Secondary 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 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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orelabrutinib and a drug called Placebo for people with secondary progressive multiple sclerosis. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orelabrutinib orally

DRUGPlacebo

Placebo orally

Locations(20)

Arizona Neuroscience Research, LLC

Phoenix, Arizona, United States

Perseverance Research Center, LLC (PRC)

Scottsdale, Arizona, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Regina Berkovich MD, PhD Inc

West Hollywood, California, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

MS and Neuromuscular Center of Excellence

Clearwater, Florida, United States

Neurology Associates

Maitland, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Josephson Wallack Munshower Neurology, Pc Suite 225

Indianapolis, Indiana, United States

KC Research Center, PA Neurology Research Dept

Roeland Park, Kansas, 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

The Boster Center for Multiple Sclerosis

Columbus, Ohio, United States

OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, United States

Premier Neurology

Greenville, South Carolina, United States

Lone Star Neurology

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman

Sherman, Texas, United States

Nmedis sp. z o.o.

Rzeszów, Rzeszów, Poland

View Full Details on ClinicalTrials.gov

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NCT07299019

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