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A Study of Orelabrutinib in Patients With Secondary 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 non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 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 Non-active Secondary Progressive Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2026-03-23
Completion Date
2030-07
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
Orelabrutinib orally
Placebo
Placebo orally
Locations (37)
Arizona Neuroscience Research, LLC
Phoenix, Arizona, United States
Perseverance Research Center, LLC (PRC)
Scottsdale, Arizona, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))
Torrance, California, United States
Regina Berkovich MD, PhD Inc
West Hollywood, California, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
MS and Neuromuscular Center of Excellence
Clearwater, Florida, United States
Neurology Associates
Maitland, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Josephson Wallack Munshower Neurology, Pc Suite 225
Indianapolis, Indiana, United States
KC Research Center, PA Neurology Research Dept
Roeland Park, Kansas, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Profound Research LLC at Oakland Neurology Center
Rochester Hills, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Boster Center for Multiple Sclerosis
Columbus, Ohio, United States
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, 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
Sherman, Texas, United States
Klinicki Bolnicki Centar Zagreb-Rebro
Zagreb, Croatia
NEUROHK, s.r.o.
Choceň, Czechia
Astra clinic (Clinic4U)
Tallinn, Harju, Estonia
Hospital of Lithuanian University of Health Sciences
Kaunas, Kauno, Lithuania
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sól
Nowa Sól, Lubusz Voivodeship, Poland
Nmedis sp. z o.o.
Rzeszów, Rzeszów, 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
MA-LEK Clinical Sp. z o.o.
Katowice, Poland
Galen Clinic
Lublin, Poland
Malva Trials
Lublin, Poland
EUROMEDIS Osrodek Badan Klinicznych
Szczecin, Poland
PRO SALUS Sp. z o.o. sp.k.
Lodz, Łódź Voivodeship, Poland
University Clinical Centre of Kragujevac
Kragujevac, Serbia