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New drug aims to stop Flare-Ups in rare autoimmune disease

NCT ID NCT05662241

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a drug called obexelimab to see if it can prevent flare-ups in people with IgG4-related disease, a rare condition where the immune system attacks the body's own tissues. About 194 adults with active disease will receive either the drug or a placebo. The main goal is to measure how long it takes for a flare to occur over one year.

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

194 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Feb 2029

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 years and older

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. Males and females, ≥ 18 years of age 2. Clinical diagnosis of IgG4-RD 3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD 4. Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy 5. Other inclusion criteria apply Exclusion Criteria: 1. Has disease in only 1 organ system whose primary manifestation is fibrosis 2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening 3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening 4. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or \< 5 half-lives of the investigational treatment, whichever is shorter, prior to screening 5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening 6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection 7. Use of B cell depleting or targeting agents within 6 months of randomization 8. Other exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

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

IgG4 related disease

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, 206, South Korea

  • Artus Health Centre

    Vancouver, British Columbia, Canada

  • Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico

    Florence, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Center for Clinical Research (Nova Scotia Health)

    Halifax, Nova Scotia, Canada

  • Centre Hospitalier Universitaire de Sherbrooke CHUS

    Sherbrooke, Quebec, Canada

  • Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

    San Luis Potosí City, Mexico

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, China

  • Emory Univeristy

    Atlanta, Georgia, 30322, United States

  • Fujita Health University Hospital

    Shinjuku-Ku, Japan

  • GI PROS Research - Dedicated Research Facility

    Naples, Florida, 34102, United States

  • Hacettepe University Faculty of Medicine

    Altındağ, Ankara, 06230, Turkey (Türkiye)

  • Haut-Lévèque Hospital Usn Building South Hospital Group

    Pessac, Bordeaux, 33604, France

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    Hiroshima, Japan

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Argentina

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, 807-8555, Japan

  • Hôpital Beaujon

    Paris, France

  • Hôpital de la Pitié Salpétrière

    Paris, France

  • Hôpitaux Universitaires de Marseille Timone

    Saint-Pierre, Marseille, 13005, France

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, Mexico

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • Kagawa University Hospital

    Hiragi, Kagawa-ken, Japan

  • Kanazawa Medical University Hospital

    Kokura, Fukuoka, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, Japan

  • Kansai Medical University Hospital

    Hirakata, Japan

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, Japan

  • Kita-Harima Medical Center

    Ono, Japan

  • LMU Klinikum der Universität München

    München, Bavaria, Germany

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Marmara University Pendik Training and Research Hospital

    Pendik, Istanbul, Turkey (Türkiye)

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Nagaoka Red Cross Hospital

    Nagaoka, Japan

  • Nagasaki University Hospital

    Nagasaki, Japan

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

    Warsaw, Masovian Voivodeship, Poland

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, Japan

  • Ospedale San Giovanni Bosco

    Turin, Piedmont, 10128, Italy

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Italy

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Sapporo Medical University Hospital

    Sapporo, Japan

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621, Japan

  • St. Marianna University Hospital

    Kawasaki, Japan

  • Stanford Medicine

    Stanford, California, 94305, United States

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, Poland

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tazuke Kofukai Medical Research Institute Kitano Hospital

    Osaka, Japan

  • The Institute of Medical Science, The University of Tokyo Hospital

    Minato-ku, Tokyo, Japan

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • Tokyo Medical Center Hospital

    Meguro City, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō-Ku, Tokyo, Japan

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhai, Hubei, China

  • Toyama University Hospital

    Toyama, Toyama, Japan

  • University of Verona

    Verona, 37134, Italy

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Vall d'Hebron University Hospital

    Barcelona, 08035, Spain

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, China

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