A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Recruiting · NCT07299019 · 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 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.
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, at the time of signing the informed consent.
- Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- 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).
- Absence of clinical relapses for at least 24 months.
Exclusion criteria
- The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
- Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History or current diagnosis of progressive multifocal leukoencephalopathy
- Active, clinically significant viral, bacterial, or fungal infection
- History of any other significant active medical condition
- History of suicidal behavior within 6 months prior to Screening
- Any prior history of malignancy
- Patients on anticoagulation, or antiplatelet therapy
- Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
- Clinically significant laboratory abnormalities at Screening.
- 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
44 locations listed across 13 US states.
- 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 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
- NEUROHK, s.r.o. - Choceň, Czechia
- Caribbean Center for Clinical Research - Guaynabo, Puerto Rico
- MA-LEK Clinical Sp. z o.o. - Katowice, Poland
- University Clinical Centre of Kragujevac - Kragujevac, Serbia
- Galen Clinic - Lublin, Poland
- Malva Trials - Lublin, Poland
- EUROMEDIS Osrodek Badan Klinicznych - Szczecin, Poland
- NNLE Jo Ann University Hospital - Tbilisi, Georgia
- Raymann, LLC - Tbilisi, Georgia
- Klinicki Bolnicki Centar Zagreb-Rebro - Zagreb, Croatia
- Astra clinic (Clinic4U) - Tallinn, Harju, Estonia
- 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
- Medical Center Nevrocentrum - Plovdiv, Plovdiv, Bulgaria
- Nmedis sp. z o.o. - Rzeszów, Rzeszów, Poland
- NZOZ Novo Med - Katowice, Silesian Voivodeship, Poland
- Diagnostic and Consultative Center Convex - Sofia, Sofia, Bulgaria
- Twoja Przychodnia PCM - Poznan, Wielkopolska, Poland
- Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy - Poznan, Wielkopolska, Poland
- PRO SALUS Sp. z o.o. sp.k. - Lodz, Łódź Voivodeship, Poland