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Promising drug aims to stop Flare-Ups in rare brain disease

NCT ID NCT05063162

Disease control Sponsor: UCB Biopharma SRL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 6 times

Summary

This study tests an investigational drug called rozanolixizumab in adults with MOG antibody-associated disease (MOGAD), a rare condition where the immune system attacks the brain and spinal cord. The main goal is to see if the drug can prevent or delay relapses (flare-ups) compared to a placebo. About 113 participants will receive either the drug or a placebo, and those who complete the initial phase can continue in an open-label extension where everyone gets the drug. The study is currently active but no longer recruiting.

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

113 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jul 2027

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 89 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: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD * Participant has history of relapsing MOGAD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization * Participant must be clinically stable at the time of the Screening Visit and during the Screening Period Exclusion Criteria: * Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant * Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP) * Participant has a current or medical history of primary immunodeficiency * Participant tests positive for aquaporin-4 antibodies at Screening * Participant has a serum total IgG level ≤ 5.5g/L

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Conditions

The condition(s) this trial relates to.

myelin oligodendrocyte glycoprotein antibody-associated disease

As listed by the trial registrant

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

Myelin oligodendrocyte glycoprotein antibody-associated disease (mog-ad) Myelin oligodendrocyte glycoprotein antibody-associated disease (mogad)

Contacts and locations

Locations

  • Mog001 20032

    Suita, Japan

  • Mog001 20049

    Kitakyushu, Japan

  • Mog001 20068

    Chiba, Japan

  • Mog001 20070

    Shinjuku-ku, Japan

  • Mog001 20143

    Kodaira, Japan

  • Mog001 20223

    Koriyama-shi, Japan

  • Mog001 20224

    Sendai, Japan

  • Mog001 20226

    Goyang-si, South Korea

  • Mog001 20227

    Sendai, Japan

  • Mog001 20228

    Ternopil, Ukraine

  • Mog001 20307

    Isehara, Japan

  • Mog001 20319

    Kyiv, Ukraine

  • Mog001 30022

    Melbourne, Australia

  • Mog001 40049

    Seville, Spain

  • Mog001 40140

    Göttingen, Germany

  • Mog001 40146

    Pavia, Italy

  • Mog001 40161

    Madrid, Spain

  • Mog001 40163

    Oxford, United Kingdom

  • Mog001 40170

    Strasbourg, France

  • Mog001 40177

    Münster, Germany

  • Mog001 40185

    Ghent, Belgium

  • Mog001 40195

    Hradec Králové, Czechia

  • Mog001 40267

    Barcelona, Spain

  • Mog001 40337

    Bern, Switzerland

  • Mog001 40341

    Málaga, Spain

  • Mog001 40350

    Murcia, Spain

  • Mog001 40485

    Coimbra, Portugal

  • Mog001 40550

    Istanbul, Turkey (Türkiye)

  • Mog001 40629

    Roma, Italy

  • Mog001 40630

    Zurich, Switzerland

  • Mog001 40646

    Verona, Italy

  • Mog001 40648

    Samsun, Turkey (Türkiye)

  • Mog001 40661

    Liverpool, United Kingdom

  • Mog001 40663

    Huddinge, Sweden

  • Mog001 40669

    Porto, Portugal

  • Mog001 40721

    Teplice, Czechia

  • Mog001 40723

    Basel, Switzerland

  • Mog001 40725

    Sancaktepe, Turkey (Türkiye)

  • Mog001 40726

    Izmir, Turkey (Türkiye)

  • Mog001 40840

    Bydgoszcz, Poland

  • Mog001 40850

    Athens, Greece

  • Mog001 50101

    Aurora, Colorado, 80045, United States

  • Mog001 50104

    Rochester, Minnesota, 55905, United States

  • Mog001 50243

    Boston, Massachusetts, 02114-3117, United States

  • Mog001 50297

    Scottsdale, Arizona, 85259-5452, United States

  • Mog001 50308

    Tampa, Florida, 33612, United States

  • Mog001 50450

    Palo Alto, California, 94304, United States

  • Mog001 50472

    Peoria, Illinois, 61637, United States

  • Mog001 50473

    Salt Lake City, Utah, 84112, United States

  • Mog001 50485

    Mexico City, Mexico

  • Mog001 50486

    Culiacán, Mexico

  • Mog001 50552

    Baltimore, Maryland, 21287, United States

  • Mog001 50553

    Washington D.C., District of Columbia, 20057, United States

  • Mog001 50568

    San Antonio, Texas, 78229, United States

  • Mog001 60033

    Porto Alegre, Brazil

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