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Clinical Trials in the USA / NCT07299019
Recruiting Phase 3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

NCT07299019 · tracked via the Priya Life Science USA tracker
Sponsor
Zenas BioPharma (USA), LLC
Phase
Phase 3
Started
2026-03-23
Last updated
2026-09-15

Condition(s) studied

Secondary Progressive Multiple Sclerosis

Investigational drug(s) / intervention(s)

OrelabrutinibPlacebo

Orelabrutinib: Orelabrutinib orally

Placebo: Placebo orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Arizona Neuroscience Research, LLC Phoenix Arizona Recruiting
Perseverance Research Center, LLC (PRC) Scottsdale Arizona Recruiting
Fullerton Neurology and Headache Center Fullerton California Recruiting
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)) Torrance California Recruiting
Regina Berkovich MD, PhD Inc West Hollywood California Recruiting
SFM Clinical Research, LLC Boca Raton Florida Recruiting
Nova Clinical Research, LLC Bradenton Florida Recruiting
MS and Neuromuscular Center of Excellence Clearwater Florida Recruiting
Neurology Associates Maitland Florida Recruiting
Aqualane Clinical Research Naples Florida Recruiting
Josephson Wallack Munshower Neurology, Pc Suite 225 Indianapolis Indiana Recruiting
KC Research Center, PA Neurology Research Dept Roeland Park Kansas Recruiting
Boston Clinical Trials Boston Massachusetts Withdrawn
Profound Research LLC at Oakland Neurology Center Rochester Hills Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
The Ohio State University Wexner Medical Center (OSUWMC) Columbus Ohio Recruiting
The Boster Center for Multiple Sclerosis Columbus Ohio Recruiting
OMRF Multiple Sclerosis Center of Excellence Oklahoma City Oklahoma Recruiting
Premier Neurology Greenville South Carolina Recruiting
Neurology Clinic, P.C. Cordova Tennessee Recruiting
Lone Star Neurology San Antonio Texas Recruiting
Texas Institute for Neurological Disorders - Sherman Sherman Texas Recruiting
Medical Center Nevrocentrum Plovdiv Plovdiv Recruiting
Diagnostic and Consultative Center Convex Sofia Sofia Recruiting
Klinicki Bolnicki Centar Zagreb-Rebro Zagreb Croatia Recruiting
NEUROHK, s.r.o. Choceň Czechia Recruiting
Astra clinic (Clinic4U) Tallinn Harju Recruiting
NNLE Jo Ann University Hospital Tbilisi Georgia Recruiting
Raymann, LLC Tbilisi Georgia Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed Pozzilli Isernia/Molise Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Kauno Recruiting
Centrum Medyczne INTERCOR Sp. z o.o. Bydgoszcz Kuyavian-Pomeranian Voivodeship Recruiting
Twoja Przychodnia Centrum Medyczne Nowa Sól Nowa Sól Lubusz Voivodeship Recruiting
Nmedis sp. z o.o. Rzeszów Rzeszów Recruiting
NZOZ Novo Med Katowice Silesian Voivodeship Recruiting
Twoja Przychodnia PCM Poznan Wielkopolska Recruiting
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy Poznan Wielkopolska Recruiting
MA-LEK Clinical Sp. z o.o. Katowice Poland Recruiting
Galen Clinic Lublin Poland Recruiting
Malva Trials Lublin Poland Recruiting

+ 4 more sites — see the full list on the official registry below.

More Zenas BioPharma (USA), LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07299019 on ClinicalTrials.gov ↗ ← All trials in the USA