A Study of IMM0306 in IgG4-Related Disease

NCT07621939 | Not Yet Recruiting Phase 2

• 1 other identifier: IMM0306-IgG4RD-301
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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

IgG4-Related Disease

Outcome Measures

Primary Outcomes (1)

• Time to disease relapse

  From Day 1 to the end of Week 26/52

Secondary Outcomes (7)

• Annualized relapse rate

  From Day 1 to the end of Week 26/52

• Cumulative glucocorticoid dose

  From Day 1 to the end of Week 52

• Proportion of relapse-free and glucocorticoid-free complete remission

  At Week 26/52

• Incidence of AEs

  From Day 1 to the end of Week 52

• Incidence of ADA

  From Day 1 to the end of Week 38

Other Outcomes (2)

• Change from baseline in B-cell subsets

  From Day 1 to the end of Week 52

• Change from baseline in complement levels

  From screening to the end of Week 52

Study Arms (3)

Phase II single arm

EXPERIMENTAL

Drug: IMM0306

Phase III treatment arm

EXPERIMENTAL

Drug: IMM0306

Phase III control arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMM0306 DRUG

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

Phase II single arm; Phase III treatment arm

Placebo DRUG

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

Phase III control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of IgG4-RD;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Wei Han

CONTACT

+8618646329327; wei.han@immuneonco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: June 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-05