A Study of Efgartigimod in Patients With IgG4-Related Disease

NCT ID: NCT07025330

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-12
• Study Completion Date: 2028-06-01

Brief Summary

The goal of this clinical trial is to learn if efgartigimod can treat IgG4-related disease in adults. The main questions it aims to answer are:

In patients with IgG4-related disease, does treatment with efgartigimod reduce the volume of the:

• lacrimal gland(s) and/or
• salivary gland(s) and/or
• pancreas

Participants will:

• Receive efgartigimod once weekly for up to 12 weeks
• Visit the clinic every one to six weeks for checkups and tests
• Be asked to complete questionnaires to see how they feel on efgartigimod

Conditions

IgG4-related Disease

Keywords

efgartigimod; IgG4-RD; IgG4-related disease; FcRn; FcRn inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

efgartigimod

Participants will be treated with efgartigimod 1000 mg subcutaneously once weekly for up to 12 weeks

Group Type: EXPERIMENTAL

Efgartigimod

Intervention Type: DRUG

efgartigimod 1000 mg subcutaneous injection given once weekly

Interventions

Efgartigimod

efgartigimod 1000 mg subcutaneous injection given once weekly

Intervention Type: DRUG

Other Intervention Names

efgartigimod alfa and hyaluronidase-qvfc

Eligibility Criteria

Inclusion Criteria

• Have a clinical diagnosis of IgG4-related disease that requires treatment in the opinion of the investigator
• Meet the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease
• Have a serum IgG4 concentration greater than or equal to 2 times the upper limit of normal at Screening
• Have involvement of the lacrimal gland(s), salivary gland(s), and/or pancreas

• If lacrimal and/or salivary glands are involved, it must be symptomatic, including but not limited to discomfort, pain, dryness, headache, or vision changes
• If the pancreas is involved, it must be asymptomatic, diffuse enlargement without signs or symptoms of obstruction or evidence of major organ dysfunction in the opinion of the investigator
• Have a prior inadequate response to, or intolerance of, glucocorticoids, or who have experienced recurrent symptoms after previous treatment with glucocorticoids
• Are not receiving current treatment with immunosuppressive medications
• All women must test negative for pregnancy and agree to use a reliable method of birth control

Exclusion Criteria

• Prior treatment with an FcRn inhibitor
• Have conventional synthetic disease-modifying antirheumatic drug (csDMARD) or immunosuppressive use as follows:

• Treatment with glucocorticoids within 28 days prior to Baseline or planned treatment during the study
• Treatment with csDMARDs including but not limited to hydroxychloroquine, methotrexate, leflunomide, or sulfasalazine within 28 days prior to Baseline or planned treatment during the study
• Treatment with cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to Baseline or planned treatment during the study
• Treatment with a janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, upadacitinib, or filgotinib within 28 days prior to Baseline or planned treatment during the study
• Treatment with a Bruton's tyrosine kinase (BTK) inhibitor including but not limited to ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib, or rilzabrutinib within 28 days prior to Baseline or planned treatment during the study
• Have biologic disease-modifying antirheumatic drug (bDMARD) use as follows:

• Treatment with etanercept, adalimumab, or anakinra within 28 days before Baseline or planned treatment during the study
• Treatment with infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab within 56 days before Baseline or planned treatment during the study
• Treatment with a B cell depleting agent including but not limited to rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab, or obexelimab ≤ 6 months prior to Baseline
• Patients who received B-cell targeted therapy > 6 and ≤ 12 months prior to Baseline must have a B-cell count that is within the laboratory reference range at Screening
• Treatment with a BAFF antagonist including but not limited to belimumab or tabalumab within 6 months before Baseline or planned treatment during the study
• Treatment with an IL-17 antagonist including but not limited to secukinumab, ixekizumab, or brodalumab within 6 months before Baseline or planned treatment during the study
• Prior treatment with other bDMARDs may be allowed at the discretion of the investigator
• A history of, or current, inflammatory or autoimmune disease (that could affect the interpretation of safety or efficacy outcomes) other than IgG4-related disease
• Evidence of active tuberculosis, HIV, or hepatitis B or C infection
• History of cancer except for skin basal or squamous cell carcinoma, cervical dysplasia or carcinoma in situ that has been treated and is considered cured > 1 year prior to Baseline, prostate cancer considered cured for > 5 years with a normal prostate specific antigen, or colon cancer considered cured > 5 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Matthew C. Baker

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew C Baker, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Travis Deal

Role: CONTACT

Phone: 650-723-7416

Email: tdeal1@stanford.edu

Angie Aberia

Role: CONTACT

Email: aberia@stanford.edu

Facility Contacts

Travis Deal

Role: primary

Other Identifiers

79851

Identifier Type: -

Identifier Source: org_study_id