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New oral drug could slow MS progression in major trial

NCT ID NCT07067463

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 38 times

Summary

This phase 3 trial tests whether the oral drug orelabrutinib can slow disability progression in people with primary progressive multiple sclerosis (PPMS). About 705 adults aged 18–60 with PPMS will receive either orelabrutinib or a placebo for up to 5 years. The study measures time to worsening disability using walking, hand function, and standard disability scales.

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 BTK inhibitor taken as a pill)
What this could lead to
If successful, this could provide a new oral treatment option to slow disability progression in people with primary progressive multiple sclerosis.
What could go wrong
This is a large phase 3 trial, but the drug may not prove effective or could have side effects. The study lasts up to 5 years, and results are not guaranteed.

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 705 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: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening. Exclusion Criteria: * Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) * Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy. * History or current diagnosis of other neurological disorders that may mimic MS * History of any other significant active medical condition * History of suicidal behavior within 6 months prior to Screening * Any prior history of malignancy if no recurrence within 5 years * Patients on anticoagulation, or antiplatelet therapy will be excluded * Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days * Clinically significant laboratory abnormalities at Screening. * Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention * 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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis primary progressive multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis (MS) primary progressive

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

    63 sites in 16 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: •••••@•••••

Locations

  • Arizona Neuroscience Research, LLC

    RECRUITING

    Pheonix, Arizona, 85032, United States

  • Astra Clinic (Clinic4U)

    RECRUITING

    Tallinn, Harju, 10617, Estonia

  • Avis Medica Hospital Pleven

    RECRUITING

    Pleven, 5800, Bulgaria

  • Caribbean Center for Clinical Research

    RECRUITING

    Guaynabo, 00968, Puerto Rico

  • Caucasus Medical Center Ltd

    RECRUITING

    Tbilisi, 0186, Georgia

  • Centrum Medyczne INTERCOR Sp. z o.o.

    RECRUITING

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

  • Centrum Medyczne NeuroProtect

    RECRUITING

    Warsaw, 01-684, Poland

  • Centrum Medyczne Pratia Katowice

    RECRUITING

    Katowice, 40-081, Poland

  • Centrum Medyczne ProNeuro Żory

    RECRUITING

    Żory, 44-240, Poland

  • ClinHouse Centrum Medyczne

    RECRUITING

    Zabrze, Pl-sl, 41-807, Poland

  • Clinic of Neurology - Clinical Center Nis

    RECRUITING

    Niš, 18000, Serbia

  • Clinical Centre Kragujevac, Neurology clinic

    RECRUITING

    Kragujevac, 34000, Serbia

  • Complejo Hospitalario Universitario A Coruna

    RECRUITING

    A Coruña, 15006, Spain

  • Cooperman Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Copernicus Podmiot Leczniczy Szpital im. M. Kopernika

    RECRUITING

    Gdansk, 80-803, Poland

  • Diagnostic and Consultative Center Convex

    RECRUITING

    Sofia, Sofia, 1680, Bulgaria

  • Euromedis Osrodek Badan Klinicznych

    RECRUITING

    Szczecin, 70-111, Poland

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Galen Clinic

    RECRUITING

    Lublin, 20-064, Poland

  • Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Galicia, 36312, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Vithas Nisa Sevilla

    RECRUITING

    Castilleja de la Cuesta, Seville, 41950, Spain

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    RECRUITING

    Pozzilli, Isemiaa/Molise, 86077, Italy

  • KC Research Center, PA Neurology Research Department

    RECRUITING

    Roeland Park, Kansas, 66205, United States

  • Klinicki Bolnicki Centar Zagreb-Rebro

    RECRUITING

    Zagreb, 10 000, Croatia

  • Limited Liability Company "Neurofocus"

    RECRUITING

    Lviv, 79029, Ukraine

  • Lone Star Neurology

    RECRUITING

    San Antonio, Texas, 78258, United States

  • MD Georgia Staff Physician MediClub Georgia

    RECRUITING

    Tbilisi, Saburtalo, 0160, Georgia

  • Malva Trials

    RECRUITING

    Lublin, 20-601, Poland

  • Medical Center Hera EOOD

    RECRUITING

    Sofia, 1510, Bulgaria

  • Medical Center Nevrocentrum

    RECRUITING

    Plovdiv, Plovdiv, 4000, Bulgaria

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Mudr. Beata Dupejova, neurologická ambulancia S.R.O.

    RECRUITING

    Banská Bystrica, 97404, Slovakia

  • NEUROHK, s.r.o.

    RECRUITING

    Choceň, 56501, Czechia

  • NNLE Jo Ann University Hospital

    RECRUITING

    Tbilisi, 0159, Georgia

  • NZOZ Neuromed M. i M. Nastaj Sp.P

    RECRUITING

    Lublin, 20-064, Poland

  • NZOZ Novo Med

    RECRUITING

    Katowice, Silesian Voivodeship, 40-584, Poland

  • Nemocnice Teplice

    RECRUITING

    Teplice, 41501, Czechia

  • Neuro Centrum Science Gmbh Albert-Schwitzer

    RECRUITING

    Erbach im Odenwald, Hesse, 64711, Germany

  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej

    RECRUITING

    Plewiska, Wielkopolska, 62-064, Poland

  • Neurology Associates, PA

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurology Clinic, P.C.

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • Nmedis sp.z o.o.

    RECRUITING

    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

  • Perseverance Research Center

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Premier Neurology

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Raymann, LLC

    RECRUITING

    Tbilisi, 0186, Georgia

  • Regina Berkovich MD, PhD Inc.

    RECRUITING

    West Hollywood, California, 90048, United States

  • Spital Clinic CF Constanta

    RECRUITING

    Constanța, Constanța County, 900123, Romania

  • Spitalul Clinic Judetean Mures

    RECRUITING

    Târgu Mureş, 540136, Romania

  • Texas Institute for Neurological Disorders

    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) L3-100

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    RECRUITING

    Nowa Sól, 67-100, Poland

  • Twoja Przychodnia PCM

    RECRUITING

    Poznan, Wielkopolska, 60-324, Poland

  • University Clinical Centre of Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Centre of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University of South Florida Department of Neurology - MS Division

    RECRUITING

    Tampa, Florida, 33612, United States

  • Velocity Clinical Research, Raleigh Neurology

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Zuyderland Medisch Centrum - Sittard-Geleen

    RECRUITING

    Sittard, Limburg, 6162-BG, Netherlands

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