NCT07299019From ClinicalTrials.govRecruiting

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Zenas BioPharma (USA), LLC
Enrolment target: 990
Started: 23 March 2026
Main results due: June 2030
Study sites: 46
Registry updated: 23 September 2026

Can you take part?

Ages 18 years to 60 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(46)

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Withdrawn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

Showing 46 of 46 sites. 45 of the 46 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07299019. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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