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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Sponsor: Zenas BioPharma (USA), LLC • ClinicalTrials.gov ID: NCT07299019

Registry updated: 2026-10-21
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Description

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.

Interventions

  • Orelabrutinib (Drug)
    Orelabrutinib orally
  • Placebo (Drug)
    Placebo orally

Eligibility criteria

Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s). 5. Absence of clinical relapses for at least 24 months. Exclusion Criteria: 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Conditions

Secondary Progressive Multiple Sclerosis

Locations

  • 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
  • University of South Florida Department of Neurology - MS Division — Tampa, 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
  • University of Massachusetts Memorial Medical Center — Worcester, 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
  • University Of New Mexico School Of Medicine — Albuquerque, New Mexico, United States
  • Mount Sinai Medical Center — New York, New York, United States
  • The Ohio State University Wexner Medical Center (OSUWMC) — Columbus, Ohio, 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
  • Medical Center Nevrocentrum — Plovdiv, Plovdiv, Bulgaria
  • Diagnostic and Consultative Center Convex — Sofia, Sofia, Bulgaria
  • Medical Center Medica Plus OOD — Veliko Tarnovo, 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
  • Raymann, LLC — Tbilisi, Georgia
  • Valeomed Kft. — Esztergom, Komarom-Esztergom Vamegye, Hungary
  • National Institute of Clinical Neurosciences — Budapest, Hungary
  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz — Tatabánya, Hungary
  • IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli, Isernia/Molise, Italy
  • 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
  • Neuro Medic Clinic — Katowice, Poland
  • Galen Clinic — Lublin, Poland
  • NZOZ Neuromed M. i M. Nastaj Sp.P — Lublin, Poland
  • Malva Trials — Lublin, Poland
  • Prywatna Lecznica Certus Sp. z o.o. — Poznan, Poland
  • EUROMEDIS Osrodek Badan Klinicznych — Szczecin, Poland
  • PRO SALUS Sp. z o.o. sp.k. — Lodz, Łódź Voivodeship, Poland
  • Caribbean Center for Clinical Research — Guaynabo, Puerto Rico
  • University Clinical Centre of Kragujevac — Kragujevac, Serbia
  • Clinic of Neurology - Clinical Center Nis — Niš, Serbia
  • CNE City Clinical Hospital #1 of Ivano-Frankivsk council — Ivano-Frankivsk, Ukraine
  • Limited Liability Company Medical Center Neuroclinic — Lviv, Ukraine
  • Limited Liability Company "Neurofocus" — Lviv, Ukraine
  • Medical Clinical Investigational Center of Medical Center LLC Health Clinic — Vinnytsia, Ukraine
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record