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A Study of IMM0306 in IgG4-Related Disease

NCT07621939 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-06-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IMM0306

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

DRUG

Placebo

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

Sponsors & Collaborators

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621939 on ClinicalTrials.gov