RecruitingPhase 3NCT07067463

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

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

Sponsor

Zenas BioPharma (USA), LLC

Enrollment

705 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis (MS) Primary Progressive

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called orelabrutinib — which blocks a protein involved in immune cell activity — can slow disability progression in people with primary progressive multiple sclerosis (PPMS), a form of MS that gradually worsens without relapses. **You may be eligible if...** - You are 18 to 60 years old - You have been diagnosed with primary progressive MS (PPMS) based on current medical criteria - Your disability has been documented as worsening in the past 24 months - Your disability score (EDSS) is between 3.0 and 6.5 **You may NOT be eligible if...** - You have a different form of MS (relapsing-remitting or secondary progressive) - You have another immune or neurological disease - You have had a malignancy in the past 5 years - You are on blood thinners or antiplatelet drugs - You have had alcohol or drug abuse issues in the past year - You have had a live vaccine within the past month Talk to your doctor to see if this trial is right for you.

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

Orally

DRUGPlacebo

Orally

Locations(44)

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

KC Research Center, PA Neurology Research Department

Roeland Park, Kansas, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cooperman Barnabas Medical Center

Livingston, New Jersey, United States

Velocity Clinical Research, Raleigh Neurology

Raleigh, North Carolina, United States

The Boster Center for Multiple Sclerosis

Columbus, Ohio, 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

Medical Center Nevrocentrum

Plovdiv, Plovdiv, Bulgaria

Diagnostic and Consultative Center Convex

Sofia, Sofia, Bulgaria

Avis Medica Hospital Pleven

Pleven, Bulgaria

Klinicki Bolnicki Centar Zagreb-Rebro

Zagreb, Croatia

NEUROHK, s.r.o.

Choceň, Czechia

Astra Clinic (Clinic4U)

Tallinn, Harju, Estonia

MD Georgia Staff Physician MediClub Georgia

Tbilisi, Saburtalo, Georgia

NNLE Jo Ann University Hospital

Tbilisi, Georgia

Raymann, LLC

Tbilisi, Georgia

Neuro Centrum Science Gmbh Albert-Schwitzer

Erbach im Odenwald, Hesse, Germany

IRCCS Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Isemiaa/Molise, Italy

Zuyderland Medisch Centrum - Sittard-Geleen

Sittard, Limburg, Netherlands

ClinHouse Centrum Medyczne

Zabrze, Pl-sl, Poland

NZOZ Novo Med

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia PCM

Poznan, Wielkopolska, Poland

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, Wielkopolska, Poland

Copernicus Podmiot Leczniczy Szpital im. M. Kopernika

Gdansk, Poland

Galen Clinic

Lublin, Poland

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, Poland

Zanamed Medical Clinic Sp.z o.o.

Lublin, Poland

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Poland

Nmedis sp.z o.o.

Rzeszów, Poland

Euromedis Osrodek Badan Klinicznych

Szczecin, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Centrum Medyczne ProNeuro Żory

Żory, Poland

Clinical Centre Kragujevac, Neurology clinic

Kragujevac, Serbia

University Clinical Centre of Kragujevac

Kragujevac, Serbia

Hospital Alvaro Cunqueiro

Vigo, Galicia, Spain

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, Seville, Spain

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

View Full Details on ClinicalTrials.gov

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NCT07067463

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