A Study of IMM0306 in IgG4-Related Disease (NCT07621939) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Study of IMM0306 in IgG4-Related Disease
125 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to disease relapse
Timeframe: From Day 1 to the end of Week 26/52
Trial details
NCT IDNCT07621939
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.