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NCT Number: NCT07621939

A Study of IMM0306 in IgG4-Related Disease

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.

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Key information

Conditions

IgG4-related Disease Autoimmune Diseases Immune System Diseases Immunoglobulin G4-Related Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMM0306

Drug

1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later

Placebo

Drug

1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later

Primary outcomes

  1. Time to disease relapse

    Time frame: From Day 1 to the end of Week 26/52

Secondary outcomes

  1. Annualized relapse rate

    Time frame: From Day 1 to the end of Week 26/52

  2. Cumulative glucocorticoid dose

    Time frame: From Day 1 to the end of Week 52

  3. Proportion of relapse-free and glucocorticoid-free complete remission

    Time frame: At Week 26/52

  4. Incidence of AEs

    Time frame: From Day 1 to the end of Week 52

  5. Incidence of ADA

    Time frame: From Day 1 to the end of Week 38

  6. Cmax

    Time frame: From Day 1 to the end of Week 29

  7. Cmin

    Time frame: From Day 1 to the end of Week 29

Other outcomes

  1. Change from baseline in B-cell subsets

    Time frame: From Day 1 to the end of Week 52

  2. Change from baseline in complement levels

    Time frame: From screening to the end of Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Han

CONTACT

[email protected]

+8618646329327

Sponsors and collaborators

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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