A Study of IMM0306 in IgG4-Related Disease

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.

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 Overview

• Status: Not yet recruiting
• Conditions: IgG4-Related Disease
• Intervention / Treatment: Drug: IMM0306; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Wei Han; Phone Number: +8618646329327; Email: wei.han@immuneonco.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase II single arm	Drug: IMM0306; 1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
Experimental: Phase III treatment arm	Drug: IMM0306; 1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
Placebo Comparator: Phase III control arm	Drug: Placebo; 1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to disease relapse	From Day 1 to the end of Week 26/52

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cmax	From Day 1 to the end of Week 29
Cmin	From Day 1 to the end of Week 29

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Immunoglobulin G4-Related Disease
• Other Study ID Numbers: IMM0306-IgG4RD-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No