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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

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orally

DRUG

Placebo

Orally

Locations (53)

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

Medical Center Hera EOOD

Sofia, 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

Caucasus Medical Center Ltd

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

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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

Malva Trials

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

Spital Clinic CF Constanta

Constanța, Constanța County, Romania

University Clinical Centre of Serbia

Belgrade, Serbia

Clinical Centre Kragujevac, Neurology clinic

Kragujevac, Serbia

University Clinical Centre of Kragujevac

Kragujevac, Serbia

Clinic of Neurology - Clinical Center Nis

Niš, Serbia

Mudr. Beata Dupejova, neurologická ambulancia S.R.O.

Banská Bystrica, Slovakia

Hospital Alvaro Cunqueiro

Vigo, Galicia, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, Seville, Spain

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain