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New drug aims to stop IgG4 disease relapses without Long-Term steroids

NCT ID NCT07621939

Disease control Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called IMM0306 in 125 people with IgG4-related disease, a condition where the immune system attacks organs causing swelling and damage. The goal is to see if IMM0306 can prevent disease flare-ups and allow patients to safely stop taking steroids. Participants receive either IMM0306 or a placebo by IV once a week for 4 weeks, repeated 6 months later, while gradually reducing their steroid dose.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 125 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Clinical diagnosis of IgG4-RD; * Meeting 2019 ACR/EULAR classification criteria with an inclusion score ≥20; * At least two organs/sites involved during the disease course; * Prior or recent IgG4-RD flare requiring initiation or continuation of GC treatment at informed consent. Exclusion Criteria: * Fibrotic manifestation as the only clinical manifestation of the current relapse; * Significant hematologic or hepatic abnormalities; * Recent B-cell-depleting therapy, alkylating agents, DMARDs or immunosuppressants; * Other chronic active immune diseases requiring long-term use of immunosuppressants; * Active malignancy or active malignancy within 10 years; * Significant cardiac disease; * Active infection or active TB; * Severe pulmonary disease; * Recent opportunistic infection; * Alcohol/drug abuse; * Pregnancy, lactation or failure to meet contraception requirements.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.