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

NCT ID NCT04540497

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 inebilizumab to see if it can prevent flare-ups in people with IgG4-related disease, a rare condition that causes swelling and damage in organs. About 135 adults who have had recent flare-ups are taking part. The main goal is to see how long it takes for a flare to happen compared to a placebo.

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

135 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Oct 2028

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.

Key Inclusion Criteria: 1. Male or female adults, ≥ 18 years of age at time of informed consent. 2. Clinical diagnosis of IgG4-RD. 3. Fulfillment of the 2019 ACR/EULAR classification criteria. 4. Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent. 5. IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD 6. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception Key Exclusion Criteria: 1. History of solid organ or cell-based transplantation or known immunodeficiency disorder. 2. Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin or prostate cancer are acceptable). 3. Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in the 6 months prior to screening. 4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening. 5. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection. 6. Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening. 7. Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2.

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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

  • Viela Bio Investigative Siite

    Tlalpan, Mexico

  • Viela Bio Investigative Site

    Palo Alto, California, 94305, United States

  • Viela Bio Investigative Site

    Atlanta, Georgia, 30322, United States

  • Viela Bio Investigative Site

    Baltimore, Maryland, 21287, United States

  • Viela Bio Investigative Site

    Boston, Massachusetts, 02114, United States

  • Viela Bio Investigative Site

    Buenos Aires, Argentina

  • Viela Bio Investigative Site

    Mendoza, Argentina

  • Viela Bio Investigative Site

    Auchenflower, Queensland, Australia

  • Viela Bio Investigative Site

    Adelaide, South Australia, Australia

  • Viela Bio Investigative Site

    Fitzroy, Australia

  • Viela Bio Investigative Site

    Sherbrooke, Canada

  • Viela Bio Investigative Site

    Hohhot, Inner Mongolia, China

  • Viela Bio Investigative Site

    Guandong, China

  • Viela Bio Investigative Site

    Shang’ai, China

  • Viela Bio Investigative Site

    Shenyang, China

  • Viela Bio Investigative Site

    Wuhan, China

  • Viela Bio Investigative Site

    Clichy, France

  • Viela Bio Investigative Site

    Lille, France

  • Viela Bio Investigative Site

    Marseille, France

  • Viela Bio Investigative Site

    Nantes, France

  • Viela Bio Investigative Site

    Pessac, France

  • Viela Bio Investigative Site

    Berlin, Germany

  • Viela Bio Investigative Site

    Lübeck, Germany

  • Viela Bio Investigative Site

    München, Germany

  • Viela Bio Investigative Site

    Hong Kong, Hong Kong

  • Viela Bio Investigative Site

    Debrecen, Hungary

  • Viela Bio Investigative Site

    Szeged, Hungary

  • Viela Bio Investigative Site

    Bangalore, India

  • Viela Bio Investigative Site

    Cork, Ireland

  • Viela Bio Investigative Site

    Kfar Saba, Israel

  • Viela Bio Investigative Site

    Petah Tikva, Israel

  • Viela Bio Investigative Site

    Tel Aviv, Israel

  • Viela Bio Investigative Site

    Tel Litwinsky, Israel

  • Viela Bio Investigative Site

    Florence, Italy

  • Viela Bio Investigative Site

    Milan, Italy

  • Viela Bio Investigative Site

    Pisa, Italy

  • Viela Bio Investigative Site

    Reggio Emilia, Italy

  • Viela Bio Investigative Site

    Torino, Italy

  • Viela Bio Investigative Site

    Verona, Italy

  • Viela Bio Investigative Site

    Fukuoka, Japan

  • Viela Bio Investigative Site

    Hokkaido, Japan

  • Viela Bio Investigative Site

    Hyōgo, Japan

  • Viela Bio Investigative Site

    Ishikawa, Japan

  • Viela Bio Investigative Site

    Kyoto, Japan

  • Viela Bio Investigative Site

    Niigata, Japan

  • Viela Bio Investigative Site

    Osaka, Japan

  • Viela Bio Investigative Site

    Tokyo, Japan

  • Viela Bio Investigative Site

    Toyama, Japan

  • Viela Bio Investigative Site

    Amsterdam, Netherlands

  • Viela Bio Investigative Site

    Rotterdam, Netherlands

  • Viela Bio Investigative Site

    Warsaw, Poland

  • Viela Bio Investigative Site

    Wroclaw, Poland

  • Viela Bio Investigative Site

    Barcelona, Spain

  • Viela Bio Investigative Site

    Madrid, Spain

  • Viela Bio Investigative Site

    Valencia, Spain

  • Viela Bio Investigative Site

    Gothenburg, Sweden

  • Viela Bio Investigative Site

    Stockholm, Sweden

  • Viela Bio Investigative Site

    Ankara, Turkey (Türkiye)

  • Viela Bio Investigative Site

    Istanbul, Turkey (Türkiye)

  • Viela Bio Investigative Site

    Leeds, United Kingdom

  • Viela Bio Investigative Site

    London, United Kingdom

  • Viela Bio Investigative Site

    Newcastle, United Kingdom

  • Viela Bio Investigative Site

    Oxford, United Kingdom

  • Viela Bio Investigative Site 1

    Toronto, Canada

  • Viela Bio Investigative Site 1

    Beijing, China

  • Viela Bio Investigative Site 2

    Toronto, Canada

  • Viela Bio Investigative Site 2

    Beijing, China

  • Viela Bio Investigative Site 2

    Osaka, Japan

  • Viela Bio Investigative Site 2

    Barcelona, Spain

  • Viela Bio Investigative Site 3

    Beijing, China

  • Viela Bio Investigative Site 4

    Beijing, China

  • Viela Bio Investigative Site 5

    Beijing, China

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