ClinicalTrials.gov record NCT07621939

A Study of IMM0306 in IgG4-Related Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2/3A study that tests whether a treatment works while continuing to check safety, in a larger group than a phase 2 study alone. It combines the aims of phase 2 and phase 3 in one protocol.
Age18 years old and older
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase II/III study evaluates the drug IMM0306 in people with IgG4‑related disease. Phase II is single-arm (all participants receive IMM0306); Phase III randomizes participants, triple-masked, to IMM0306 or placebo. Dosing is by intravenous infusion once weekly for four weeks, with the same course repeated six months later; participants start a planned steroid (glucocorticoid) taper from Day 1. The study includes clinical assessments, labs, imaging, ECGs, and blood sampling for drug levels and anti-drug antibodies.

What it is studying. Whether IMM0306 reduces the risk of disease relapse in people with IgG4‑related disease, plus the drug's safety and tolerability. The study will also measure how the drug behaves in the body (pharmacokinetics) and whether participants develop anti-drug antibodies. Secondary measures include relapse rate, cumulative glucocorticoid use, and rates of relapse-free and glucocorticoid-free complete remission.

What the researchers hope to learn. To find out if IMM0306 reduces the risk of disease relapse in IgG4‑related disease; to describe its safety and tolerability; to measure pharmacokinetics and the incidence of anti-drug antibodies; and to assess relapse rate, cumulative glucocorticoid dose, and relapse-free/glucocorticoid-free complete remission.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this clinical trial is to learn if IMM0306 works to reduce the risk of disease relapse in participants with IgG4-related disease (IgG4-RD). It will also learn about the safety and tolerability of IMM0306. The main questions it aims to answer are:

  • Does IMM0306 reduce the risk of disease relapse in participants with IgG4-RD?
  • What medical problems do participants have when receiving IMM0306?
  • How does IMM0306 behave in the body, and does the body develop anti-drug antibodies against IMM0306? In the Phase II part, all participants will receive IMM0306. In the Phase III part, researchers will compare IMM0306 with placebo to evaluate whether IMM0306 reduces the risk of disease relapse in participants with IgG4-RD.

Participants will:

  • Receive IMM0306 or placebo by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
  • Start a planned glucocorticoid taper from Day 1 and gradually reduce oral prednisone or equivalent until complete discontinuation after 8 weeks
  • Visit the study site for efficacy and safety assessments, including disease relapse assessment, IgG4-RD responder index assessment, laboratory tests, imaging examinations, electrocardiograms, pharmacokinetic sampling, immunogenicity sampling, biomarker sampling, and adverse event assessment.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • IMM0306
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive intravenous infusions of IMM0306 (1.6 mg/kg) once weekly for 4 consecutive weeks, with the same 4‑week course repeated six months later; in Phase III participants will be randomized to IMM0306 or matching placebo. All participants start a planned glucocorticoid (steroid) taper from Day 1 aiming for complete discontinuation after 8 weeks. Study visits include assessments for disease relapse and the IgG4‑RD responder index, safety checks, blood samples for drug levels and anti‑drug antibodies, biomarker sampling, imaging exams, ECGs, and reporting of adverse events.

How the study is structured. An interventional Phase II/III treatment study. Phase II: all participants receive IMM0306. Phase III: participants are randomized and triple-masked to receive IMM0306 or placebo in parallel groups. Treatment is given by IV infusion once weekly for four weeks, repeated at six months; participants follow a planned oral steroid taper from Day 1. Follow-up includes relapse assessments, safety monitoring, laboratory tests, imaging, ECGs, and blood sampling for drug levels and antibodies.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
July 2026 (estimated)
Primary completion
May 2030 (estimated)
Study completion
May 2030 (estimated)
Target enrollment
125 participants (estimated)
Last updated on registry
Jun 2, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

relapse
A condition that improved with treatment and has since returned or worsened.
Phase II
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Phase III
A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
glucocorticoid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
pharmacokinetic
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
adverse event
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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