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A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Sponsor: Zenas BioPharma (USA), LLC
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
Orelabrutinib
Orally
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