A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Start Date
3/23/2026
Completion Date
7/1/2030
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 Criteria
Age Range: 18 years to 60 years
Interventions
Orelabrutinib
Placebo
Conditions
Locations
Arizona Neuroscience Research, LLC
Pheonix, Arizona 85032
United States
Perseverance Research Center
Scottsdale, Arizona 85253
United States
Regina Berkovich MD, PhD Inc.
West Hollywood, California 90048
United States
Nova Clinical Research, LLC
Bradenton, Florida 34209
United States
Neurology Associates, PA
Maitland, Florida 32751
United States
KC Research Center, PA Neurology Research Department
Roeland Park, Kansas 66205
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United States
Velocity Clinical Research, Raleigh Neurology
Raleigh, North Carolina 27607
United States
The Boster Center for Multiple Sclerosis
Columbus, Ohio 43235
United States
Premier Neurology
Greenville, South Carolina 29605
United States
Neurology Clinic, P.C.
Cordova, Tennessee 38018
United States
Lone Star Neurology
San Antonio, Texas 78258
United States
Texas Institute for Neurological Disorders
Sherman, Texas 75092
United States
Medical Center Nevrocentrum
Plovdiv, Plovdiv 4000
Bulgaria
Diagnostic and Consultative Center Convex
Sofia, Sofia 1680
Bulgaria
Avis Medica Hospital Pleven
Pleven, 5800
Bulgaria
Klinicki Bolnicki Centar Zagreb-Rebro
Zagreb, 10 000
Croatia
NEUROHK, s.r.o.
Choceň, 56501
Czechia
Astra Clinic (Clinic4U)
Tallinn, Harju 10617
Estonia
MD Georgia Staff Physician MediClub Georgia
Tbilisi, Saburtalo 0160
Georgia
NNLE Jo Ann University Hospital
Tbilisi, 0159
Georgia
Raymann, LLC
Tbilisi, 0186
Georgia
Neuro Centrum Science Gmbh Albert-Schwitzer
Erbach im Odenwald, Hesse 64711
Germany
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isemiaa/Molise 86077
Italy
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard, Limburg 6162-BG
Netherlands
ClinHouse Centrum Medyczne
Zabrze, Pl-sl 41-807
Poland
NZOZ Novo Med
Katowice, Silesian Voivodeship 40-584
Poland
Twoja Przychodnia PCM
Poznan, Wielkopolska 60-324
Poland
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
Poznan, Wielkopolska 61-853
Poland
Galen Clinic
Lublin, 20-064
Poland
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, 20-064
Poland
Zanamed Medical Clinic Sp.z o.o.
Lublin, 20-601
Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, 67-100
Poland
Nmedis sp.z o.o.
Rzeszów, 35-323
Poland
Euromedis Osrodek Badan Klinicznych
Szczecin, 70-111
Poland
Centrum Medyczne NeuroProtect
Warsaw, 01-684
Poland
Centrum Medyczne ProNeuro Żory
Żory, 44-240
Poland
University Clinical Centre of Kragujevac
Kragujevac, 34000
Serbia
Hospital Alvaro Cunqueiro
Vigo, Galicia 36312
Spain
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Seville 41950
Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
Spain