A Study of Efgartigimod in Patients With IgG4-Related Disease

NCT07025330 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 79851
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in volume on FDG-PET/MRI of lacrimal gland(s) and/or

  From Baseline to Week 12

• Change in volume on FDG-PET/MRI of salivary gland(s) and/or

  Salivary glands include parotid glands, submandibular glands, sublingual glands

  From Baseline to Week 12

• Change in volume of pancreas on FDG-PET/MRI

  From Baseline to Week 12

Secondary Outcomes (37)

• Change in FDG avidity (SUVmax) of lacrimal glands on PET

  Baseline to Week 12

• Change in FDG avidity (SUVmean) of lacrimal glands on PET

  Baseline to Week 12

• Change in FDG avidity (total gland glycolysis) of lacrimal glands on PET

  Baseline to Week 12

• Change in FDG avidity (SUVmax) of salivary glands on PET

  Baseline to Week 12

• Change in FDG avidity (SUVmean) of salivary glands on PET

  Baseline to Week 12

Study Arms (1)

efgartigimod

EXPERIMENTAL

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

Drug: Efgartigimod

Interventions

Efgartigimod DRUG

efgartigimod 1000 mg subcutaneous injection given once weekly

Also known as: efgartigimod alfa and hyaluronidase-qvfc

efgartigimod

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304-2210, United States

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

efgartigimod alfa

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Matthew C Baker, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Travis Deal

CONTACT

650-723-7416; tdeal1@stanford.edu

Angie Aberia

CONTACT

aberia@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)