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New pill could slow MS disability in major trial

NCT ID NCT07299019

Disease control Sponsor: Zenas BioPharma (USA), LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 27 times

Summary

This Phase 3 trial tests an oral drug called orelabrutinib against a placebo in about 990 people with non-active secondary progressive multiple sclerosis (MS). The goal is to see if the drug can delay worsening disability over 24 to 60 months. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors will know which they are getting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Orelabrutinib (a drug taken orally that targets a protein called BTK to potentially slow disability progression)
What this could lead to
If it works, this could provide a new treatment option to slow disability progression in people with non-active secondary progressive multiple sclerosis.
What could go wrong
This is a large Phase 3 trial, but it is still experimental. The drug may not prove effective in slowing disability, and side effects are possible. Results will take years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 990 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Secondary progressive multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    43 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Arizona Neuroscience Research, LLC

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • Astra clinic (Clinic4U)

    RECRUITING

    Tallinn, Harju, 10617, Estonia

  • Boston Clinical Trials

    WITHDRAWN

    Boston, Massachusetts, 02131, United States

  • Caribbean Center for Clinical Research

    RECRUITING

    Guaynabo, 00969, Puerto Rico

  • Centrum Medyczne INTERCOR Sp. z o.o.

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland

  • Diagnostic and Consultative Center Convex

    RECRUITING

    Sofia, Sofia, 1680, Bulgaria

  • EUROMEDIS Osrodek Badan Klinicznych

    RECRUITING

    Szczecin, 70-111, Poland

  • Fullerton Neurology and Headache Center

    RECRUITING

    Fullerton, California, 92835, United States

  • Galen Clinic

    RECRUITING

    Lublin, 20-064, Poland

  • Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))

    RECRUITING

    Torrance, California, 90502-2006, United States

  • Hospital of Lithuanian University of Health Sciences

    RECRUITING

    Kaunas, Kauno, 50161, Lithuania

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    RECRUITING

    Pozzilli, Isernia/Molise, 86077, Italy

  • Josephson Wallack Munshower Neurology, Pc Suite 225

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • KC Research Center, PA Neurology Research Dept

    RECRUITING

    Roeland Park, Kansas, 66205, United States

  • Klinicki Bolnicki Centar Zagreb-Rebro

    RECRUITING

    Zagreb, 10 000, Croatia

  • Lone Star Neurology

    RECRUITING

    San Antonio, Texas, 78258, United States

  • MA-LEK Clinical Sp. z o.o.

    RECRUITING

    Katowice, 40-571, Poland

  • MS and Neuromuscular Center of Excellence

    RECRUITING

    Clearwater, Florida, 33761, United States

  • Malva Trials

    RECRUITING

    Lublin, 20-601, Poland

  • Medical Center Nevrocentrum

    RECRUITING

    Plovdiv, Plovdiv, 4000, Bulgaria

  • NEUROHK, s.r.o.

    RECRUITING

    Choceň, 56501, Czechia

  • NNLE Jo Ann University Hospital

    RECRUITING

    Tbilisi, 0159, Georgia

  • NZOZ Novo Med

    RECRUITING

    Katowice, Silesian Voivodeship, 40-584, Poland

  • Neurology Associates

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurology Clinic, P.C.

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • Nmedis sp. z o.o.

    RECRUITING

    Rzeszów, Rzeszów, 35-323, Poland

  • Nova Clinical Research, LLC

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

    RECRUITING

    Poznan, Wielkopolska, 61-853, Poland

  • OMRF Multiple Sclerosis Center of Excellence

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • PRO SALUS Sp. z o.o. sp.k.

    RECRUITING

    Lodz, Łódź Voivodeship, 91-743, Poland

  • Perseverance Research Center, LLC (PRC)

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Premier Neurology

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Profound Research LLC at Oakland Neurology Center

    RECRUITING

    Rochester Hills, Michigan, 48307, United States

  • Raymann, LLC

    RECRUITING

    Tbilisi, 0186, Georgia

  • Regina Berkovich MD, PhD Inc

    RECRUITING

    West Hollywood, California, 90048, United States

  • SFM Clinical Research, LLC

    RECRUITING

    Boca Raton, Florida, 33487, United States

  • Texas Institute for Neurological Disorders - Sherman

    RECRUITING

    Sherman, Texas, 75092, United States

  • The Boster Center for Multiple Sclerosis

    RECRUITING

    Columbus, Ohio, 43235, United States

  • The Ohio State University Wexner Medical Center (OSUWMC)

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Twoja Przychodnia Centrum Medyczne Nowa Sól

    RECRUITING

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • Twoja Przychodnia PCM

    RECRUITING

    Poznan, Wielkopolska, 60-324, Poland

  • University Clinical Centre of Kragujevac

    RECRUITING

    Kragujevac, 3400, Serbia

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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