Tests orelabrutinib against placebo in secondary progressive multiple sclerosis
Tests orelabrutinib, compared with placebo, in adults with non-active secondary progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Albuquerque, Boca Raton, Boston, Bradenton, Clearwater, Columbus, Cordova, Fullerton, Greenville, Indianapolis, Kansas City, Maitland, Naples, New York, Oklahoma City, Phoenix, Rochester Hills, Roeland Park, San Antonio, Scottsdale, Sherman, St Louis, Tampa, Torrance, West Hollywood, and Worcester, United StatesSee the 27 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
- Which type of multiple sclerosis (MS) has your doctor told you that you have?
- In the past 2 years, have you had a relapse (a flare-up of new or worse MS symptoms)?
- Do you have another disease of the immune system, or a long-term infection such as hepatitis B, hepatitis C or HIV?
- Have you ever had cancer?
Source: NCT07299019, who can take part
Where in United States
- University of New Mexico, School of MedicineAlbuquerque, United StatesTaking people
- SFM Clinical Research LLCBoca Raton, United StatesTaking people
- Boston Clinical TrialsBoston, United StatesNo longer taking part
- Nova Clinical Research, LLCBradenton, United StatesTaking people
- MS and Neuromuscular Center of ExcellenceClearwater, United StatesTaking people
- The Boster Center for Multiple SclerosisColumbus, United StatesTaking people
- The Ohio State University Wexner Medical Center (OSUWMC)Columbus, United StatesTaking people
- Neurology Clinic, P.C.Cordova, United StatesTaking people
- Fullerton Neurology and Headache CenterFullerton, United StatesTaking people
- Premier NeurologyGreenville, United StatesTaking people
- Josephson Wallack Munshower Neurology, Pc Suite 225Indianapolis, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Neurology AssociatesMaitland, United StatesTaking people
- Aqualane Clinical ResearchNaples, United StatesTaking people
- Mount SInai Medical CenterNew York, United StatesTaking people
- OMRF Multiple Sclerosis Center of ExcellenceOklahoma City, United StatesTaking people
- Arizona Neuroscience Research, LLCPhoenix, United StatesTaking people
- Profound Research LLC at Oakland Neurology CenterRochester Hills, United StatesTaking people
- KC Research Center, PA Neurology Research DeptRoeland Park, United StatesTaking people
- Lone Star NeurologySan Antonio, United StatesTaking people
- Perseverance Research Center, LLC (PRC)Scottsdale, United StatesTaking people
- Texas Institute for Neurological Disorders - ShermanSherman, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- University of South Florida Department of Neurology - MS DivisionTampa, United StatesTaking people
- Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))Torrance, United StatesTaking people
- Regina Berkovich MD PhD IncWest Hollywood, United StatesTaking people
- University of Massachusetts Memorial Medical CenterWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zenas BioPharma (USA), LLC
- Trial code
- NCT07299019EU 2025-524322-18-00
- Record updated
- 4 November 2026
- Original 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.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
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.
Inclusion: 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: History of suicidal behavior within 6 months prior to Screening; Patients on anticoagulation, or antiplatelet therapy; Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days; 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; Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy; History or current diagnosis of other neurological disorders that may mimic MS; Active, clinically significant viral, bacterial, or fungal infection; History of any other significant active medical condition; Any prior history of malignancy; Clinically significant laboratory abnormalities at Screening; The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria; History or current diagnosis of progressive multifocal leukoencephalopathy.