IgG4-Related DiseasePhase 2/3NCT07621939
A Study of IMM0306 in IgG4-Related Disease
A Phase 2/3 study testing IMM0306 in people with IgG4-Related Disease, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgG4-Related Disease
- What is being tested?
- IMM0306
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to May 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Active infection or active TB;
- Severe pulmonary disease;
- Recent opportunistic infection;
- Alcohol/drug abuse;
- Pregnancy, lactation or failure to meet contraception requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)
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.
Read more
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
- IgG4-Related Disease
- Being tested
- IMM0306, Placebo
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM0306Drug
1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
PlaceboDrug
1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
| Study group | Role | What they receive |
|---|---|---|
| Phase II single arm | Experimental | Not described Receives: Drug: IMM0306 |
| Phase III treatment arm | Experimental | Not described Receives: Drug: IMM0306 |
| Phase III control arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease relapse
Measured: From Day 1 to the end of Week 26/52
Secondary outcomes (7)
Annualized relapse rate
Measured: From Day 1 to the end of Week 26/52
Cumulative glucocorticoid dose
Measured: From Day 1 to the end of Week 52
Proportion of relapse-free and glucocorticoid-free complete remission
Measured: At Week 26/52
Incidence of AEs
Measured: From Day 1 to the end of Week 52
Incidence of ADA
Measured: From Day 1 to the end of Week 38
Cmax
Measured: From Day 1 to the end of Week 29
Cmin
Measured: From Day 1 to the end of Week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-Related DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621939
- Sponsor's protocol ID
- IMM0306-IgG4RD-301
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)
- ClinicalTrials.gov ID
- NCT07621939
- Acronym / sponsor ID
- IMM0306-IgG4RD-301
- Conditions
- IgG4-Related Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase II single arm | Experimental | Drug: IMM0306 |
| Phase III treatment arm | Experimental | Drug: IMM0306 |
| Phase III control arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM03061.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later | Drug | Phase II single arm, Phase III treatment arm |
| Placebo1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later | Drug | Phase III control arm |
Primary outcome
Time to disease relapse
Time frame: From Day 1 to the end of Week 26/52
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IMM0306 in people with IgG4-Related Disease, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Han (+8618646329327, wei.han@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease relapse (time frame: From Day 1 to the end of Week 26/52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.