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New MS drug shows promise in reducing brain lesions

NCT ID NCT06564311

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether obexelimab can safely reduce brain lesions in people with relapsing multiple sclerosis (MS). About 93 adults with active relapses or recent MRI lesions will receive either the drug or a placebo. The main goal is to count new brain lesions on MRI scans over the study period.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 93 people

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

Started

Aug 2024

Expected to finish

Feb 2026

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. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria 2. An EDSS of ≤ 5.5 at the Screening Visit 3. Must have documentation of: 1. . at least 1 relapse within the previous year OR 2. . ≥ 2 relapses within the past 2 years OR 3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening 4. Not of childbearing potential or willing to follow contraceptive guidance Exclusion Criteria: 1. Primary progressive MS or secondary progressive MS without relapses 2. Meet criteria for neuromyelitis optica spectrum disorder 3. Relapse in the 30 days prior to randomization 4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record) 5. Has \> 20 Gd+ lesions on brain MRI at screening

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing multiple sclerosis

Contacts and locations

Locations

  • AZ Delta-Deltalaan 1

    Roeselare, Belgium

  • Aalborg Universitetshospital

    Aalborg, Denmark

  • Aqualine Clinical Research

    Naples, Florida, 35105, United States

  • Attikon University General Hospital

    Chaïdári, Greece

  • Barts Health NHS Trust

    London, United Kingdom

  • Boster Center for MS

    Columbus, Ohio, 43235, United States

  • Center for Neurological Disorders

    Greenfield, Wisconsin, 53228, United States

  • Center for Neurology and Spine

    Phoenix, Arizona, 85032, United States

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Czechia

  • Fondazione Isituto G. Giglio di Cefalu

    Cefalù, Italy

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Italy

  • General University Hospital Praha

    Prague, Czechia

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Hospipal La Fe Valencia

    Valencia, Spain

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, Spain

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, Spain

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, Spain

  • Hospital Virgen Macarena

    Seville, Spain

  • Infusion Associates Plymouth

    Plymouth, Minnesota, 55446, United States

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Italy

  • Klinicki bolnicki centar Zagreb

    Zagreb, Croatia

  • Leicester General Hospital

    Leicester, United Kingdom

  • M.A. LEK A.M. Maciejowsy Spolka Cywilna

    Katowice, Poland

  • MS Center for Innovations in Care

    St Louis, Missouri, 63131, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Morriston Hospital

    Swansea, United Kingdom

  • Nemocnice Jihlava

    Jihlava, Czechia

  • Neuro-logisch Wien

    Vienna, Austria

  • Neurocentrum Bydgoszcz sp.z o.o.

    Bydgoszcz, Poland

  • North Central Neurology

    Cullman, Alabama, 35058, United States

  • North Texas Institute of Neurology and Headache

    Plano, Texas, 75024, United States

  • People's Hospital of Xinjiang Uyaur Autonomous Region

    Ürümqi, China

  • Perseverance Research Center

    Scottsdale, Arizona, 85253, United States

  • Regina Berkovich MD PhD, Inc

    West Hollywood, California, 90048, United States

  • Rehabilitation & MS Center, Noorderhart Hospital

    Overpelt, Belgium

  • The First Affiliation Hospital of Soochow University

    Suzhou, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Tiantan Hospital, Capital Medical University

    Beijing, China

  • Tongji Hospital, Tongji Medical Center of HUST

    Wuhan, China

  • University General Hospital of Larissa

    Larissa, Greece

  • University of Florence

    Florence, Italy

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of South Florida

    Tampa, Florida, 33620, United States

  • Wielospecjalistyczne Centrum Medyczne Ibismed

    Zabrze, Poland

  • Zanamed Medical Clinic Sp z o.o.

    Lublin, Poland

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