A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Recruiting · NCT07067463 · Interventional (participants receive a specific treatment) · Lead sponsor: Zenas BioPharma (USA), LLC
View the official record on ClinicalTrials.gov →Interventions studied
OrelabrutinibPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 12 US states.
- 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
- University of South Florida Department of Neurology - MS Division - Tampa, Florida, 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
- Complejo Hospitalario Universitario A Coruna - A Coruña, Spain
- Mudr. Beata Dupejova, neurologická ambulancia S.R.O. - Banská Bystrica, Slovakia
- University Clinical Centre of Serbia - Belgrade, Serbia
- NEUROHK, s.r.o. - Choceň, Czechia
- Copernicus Podmiot Leczniczy Szpital im. M. Kopernika - Gdansk, Poland
- Caribbean Center for Clinical Research - Guaynabo, Puerto Rico
- Fakultni Nemocnice Hradec Kralove - Hradec Králové, Czechia
- Centrum Medyczne Pratia Katowice - Katowice, Poland
- Clinical Centre Kragujevac, Neurology clinic - Kragujevac, Serbia
- University Clinical Centre of Kragujevac - Kragujevac, Serbia
- Galen Clinic - Lublin, Poland
- NZOZ Neuromed M. i M. Nastaj Sp.P - Lublin, Poland
- Malva Trials - Lublin, Poland
- Limited Liability Company "Neurofocus" - Lviv, Ukraine
- Clinic of Neurology - Clinical Center Nis - Niš, Serbia
- Twoja Przychodnia Centrum Medyczne Nowa Sol - Nowa Sól, Poland
- Avis Medica Hospital Pleven - Pleven, Bulgaria
- Nmedis sp.z o.o. - Rzeszów, Poland
- Medical Center Hera EOOD - Sofia, Bulgaria
- Euromedis Osrodek Badan Klinicznych - Szczecin, Poland
- NNLE Jo Ann University Hospital - Tbilisi, Georgia
- Caucasus Medical Center Ltd - Tbilisi, Georgia
- Raymann, LLC - Tbilisi, Georgia
- Nemocnice Teplice - Teplice, Czechia
- Spitalul Clinic Judetean Mures - Târgu Mureş, Romania
- Centrum Medyczne NeuroProtect - Warsaw, Poland
- Klinicki Bolnicki Centar Zagreb-Rebro - Zagreb, Croatia
- Centrum Medyczne ProNeuro Żory - Żory, Poland
- Spital Clinic CF Constanta - Constanța, Constanța County, Romania
- Hospital Alvaro Cunqueiro - Vigo, Galicia, Spain
- Astra Clinic (Clinic4U) - Tallinn, Harju, Estonia
- Neuro Centrum Science Gmbh Albert-Schwitzer - Erbach im Odenwald, Hesse, Germany
- IRCCS Istituto Neurologico Mediterraneo Neuromed - Pozzilli, Isemiaa/Molise, Italy
- Centrum Medyczne INTERCOR Sp. z o.o. - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Zuyderland Medisch Centrum - Sittard-Geleen - Sittard, Limburg, Netherlands
- Hospital Universitario 12 de Octubre - Madrid, Madrid, Spain
- Hospital Universitario Puerta de Hierro de Majadahonda - Majadahonda, Madrid, Spain
- ClinHouse Centrum Medyczne - Zabrze, Pl-sl, Poland
- Medical Center Nevrocentrum - Plovdiv, Plovdiv, Bulgaria
- MD Georgia Staff Physician MediClub Georgia - Tbilisi, Saburtalo, Georgia
- Hospital Vithas Nisa Sevilla - Castilleja de la Cuesta, Seville, Spain
- NZOZ Novo Med - Katowice, Silesian Voivodeship, Poland
- Diagnostic and Consultative Center Convex - Sofia, Sofia, Bulgaria
Showing 60 of 63 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →