A Phase 2/3 interventional study of IMM0306 and Placebo in IgG4-Related Disease, sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Phase 2/3, Interventional, and Treatment
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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:
Participants will:
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
This study's planned enrollment of 125 is above the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Browse Immunoglobulin G4-Related Disease studies →ImmuneOnco Biopharmaceuticals (Shanghai) Inc. is the lead sponsor of 23 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IMM0306
Drug: IMM0306
Drug: Placebo
1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
Time to disease relapse
Time frame: From Day 1 to the end of Week 26/52
Annualized relapse rate
Time frame: From Day 1 to the end of Week 26/52
Cumulative glucocorticoid dose
Time frame: From Day 1 to the end of Week 52
Proportion of relapse-free and glucocorticoid-free complete remission
Time frame: At Week 26/52
Incidence of AEs
Time frame: From Day 1 to the end of Week 52
Incidence of ADA
Time frame: From Day 1 to the end of Week 38
Cmax
Time frame: From Day 1 to the end of Week 29
Cmin
Time frame: From Day 1 to the end of Week 29
Change from baseline in B-cell subsets
Time frame: From Day 1 to the end of Week 52
Change from baseline in complement levels
Time frame: From screening to the end of Week 52
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for May 2030, 46 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amulirafusp alfa
Immunoglobulin G4-Related Disease →
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.