A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 18 to 60 years of age, inclusive
• Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria
• Participant must have documented evidence of disability progression observed during the 24 months before screening.
• Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.
Locations
United States
Arizona
Arizona Neuroscience Research, LLC
RECRUITING
Pheonix
Perseverance Research Center
RECRUITING
Scottsdale
California
Regina Berkovich MD, PhD Inc.
RECRUITING
West Hollywood
Florida
Nova Clinical Research, LLC
RECRUITING
Bradenton
Neurology Associates, PA
RECRUITING
Maitland
Kansas
KC Research Center, PA Neurology Research Department
RECRUITING
Roeland Park
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Velocity Clinical Research, Raleigh Neurology
RECRUITING
Raleigh
New Jersey
Cooperman Barnabas Medical Center
RECRUITING
Livingston
Ohio
The Boster Center for Multiple Sclerosis
RECRUITING
Columbus
The Ohio State University Wexner Medical Center (OSUWMC) L3-100
RECRUITING
Columbus
South Carolina
Premier Neurology
RECRUITING
Greenville
Tennessee
Neurology Clinic, P.C.
RECRUITING
Cordova
Texas
Lone Star Neurology
RECRUITING
San Antonio
Texas Institute for Neurological Disorders
RECRUITING
Sherman
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Bulgaria
Avis Medica Hospital Pleven
RECRUITING
Pleven
Medical Center Nevrocentrum
RECRUITING
Plovdiv
Diagnostic and Consultative Center Convex
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Croatia
Klinicki Bolnicki Centar Zagreb-Rebro
RECRUITING
Zagreb
Estonia
Astra Clinic (Clinic4U)
RECRUITING
Tallinn
Georgia
Caucasus Medical Center Ltd
RECRUITING
Tbilisi
MD Georgia Staff Physician MediClub Georgia
RECRUITING
Tbilisi
NNLE Jo Ann University Hospital
RECRUITING
Tbilisi
Raymann, LLC
RECRUITING
Tbilisi
Germany
Neuro Centrum Science Gmbh Albert-Schwitzer
RECRUITING
Erbach Im Odenwald
Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
RECRUITING
Sittard
Poland
Centrum Medyczne INTERCOR Sp. z o.o.
RECRUITING
Bydgoszcz
Copernicus Podmiot Leczniczy Szpital im. M. Kopernika
RECRUITING
Gdansk
NZOZ Novo Med
RECRUITING
Katowice
Galen Clinic
RECRUITING
Lublin
Malva Trials
RECRUITING
Lublin
NZOZ Neuromed M. i M. Nastaj Sp.P
RECRUITING
Lublin
Twoja Przychodnia Centrum Medyczne Nowa Sol
RECRUITING
Nowa Sól
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
RECRUITING
Plewiska
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
RECRUITING
Poznan
Twoja Przychodnia PCM
RECRUITING
Poznan
Nmedis sp.z o.o.
RECRUITING
Rzeszów
Euromedis Osrodek Badan Klinicznych
RECRUITING
Szczecin
Centrum Medyczne NeuroProtect
RECRUITING
Warsaw
ClinHouse Centrum Medyczne
RECRUITING
Zabrze
Centrum Medyczne ProNeuro Żory
RECRUITING
Żory
Puerto Rico
Caribbean Center for Clinical Research
RECRUITING
Guaynabo
Romania
Spital Clinic CF Constanta
RECRUITING
Constanța
Spitalul Clinic Judetean Mures
RECRUITING
Târgu Mureş
Serbia
University Clinical Centre of Serbia
RECRUITING
Belgrade
Clinical Centre Kragujevac, Neurology clinic
RECRUITING
Kragujevac
University Clinical Centre of Kragujevac
RECRUITING
Kragujevac
Clinic of Neurology - Clinical Center Nis
RECRUITING
Niš
Slovakia
Mudr. Beata Dupejova, neurologická ambulancia S.R.O.
RECRUITING
Banská Bystrica
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital Vithas Nisa Sevilla
RECRUITING
Castilleja De La Cuesta
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
RECRUITING
Majadahonda
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Patient and Medical Information
clinicaltrialsinfo@zenasbio.com
833-269-4696
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2030-07
Participants
Target number of participants: 705
Treatments
Experimental: Orelabrutinib Group
Placebo_comparator: Placebo Group
Related Therapeutic Areas
Sponsors
Leads: Zenas BioPharma (USA), LLC