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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Sponsor: Zenas BioPharma (USA), LLC • ClinicalTrials.gov ID: NCT07067463

Registry updated: 2026-10-20
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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 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.

Interventions

  • Orelabrutinib (Drug)
    Orally
  • Placebo (Drug)
    Orally

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) * Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy. * History or current diagnosis of other neurological disorders that may mimic MS * History of any other significant active medical condition * History of suicidal behavior within 6 months prior to Screening * Any prior history of malignancy if no recurrence within 5 years * Patients on anticoagulation, or antiplatelet therapy will be excluded * Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days * Clinically significant laboratory abnormalities at Screening. * Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention * Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening * History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Conditions

Multiple Sclerosis (MS) Primary Progressive

Locations

  • 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
  • Neurological Services of Orlando — Orlando, Florida, United States
  • University of South Florida Department of Neurology - MS Division — Tampa, Florida, United States
  • University of Kansas Medical Center — Kansas City, Kansas, 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 Ohio State University Wexner Medical Center (OSUWMC) L3-100 — Columbus, Ohio, 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 College of Wisconsin — Milwaukee, Wisconsin, 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
  • Medical Center Medica Plus OOD — Veliko Tarnovo, Bulgaria
  • Klinicki Bolnicki Centar Zagreb-Rebro — Zagreb, Croatia
  • NEUROHK, s.r.o. — Choceň, Czechia
  • Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
  • Nemocnice Teplice — Teplice, 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
  • University G. D'Annunzio of Chieti-Pescara — Chieti, 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
  • Neuro Medic Clinic — Katowice, Upper Silesia, Poland
  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej — Plewiska, Wielkopolska, 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
  • Centrum Medyczne Pratia Katowice — Katowice, 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
  • MTZ Clinical Researcz Powered by pratia — Warsaw, Poland
  • Centrum Medyczne ProNeuro Żory — Żory, Poland
  • Caribbean Center for Clinical Research — Guaynabo, Puerto Rico
  • Spital Clinic CF Constanta — Constanța, Constanța County, Romania
  • Spitalul Clinic Judetean Mures — Târgu Mureş, 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
  • 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
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Official Source

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

View Official Record