Actively Recruiting
A Study of Efgartigimod in Patients With IgG4-Related Disease
Led by Stanford University · Updated on 2026-02-10
5
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Efgartigimod in Patients With IgG4-Related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 90 years
- Clinical diagnosis of IgG4-related disease requiring treatment
- Meet the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease
- Serum IgG4 concentration at least twice the upper limit of normal at screening
- Involvement of lacrimal gland(s), salivary gland(s), and/or pancreas
- If lacrimal or salivary glands are involved, symptoms such as discomfort, pain, dryness, headache, or vision changes must be present
- If pancreas is involved, it must be asymptomatic with diffuse enlargement and no major organ dysfunction
- Prior inadequate response or intolerance to glucocorticoids, or recurrent symptoms after glucocorticoid treatment
- Not currently receiving immunosuppressive medications
- Women must test negative for pregnancy and agree to use reliable birth control
You will not qualify if you...
- Any exclusion criteria listed in the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease
- Prior treatment with an FcRn inhibitor
- Treatment with glucocorticoids within 28 days before baseline or planned during the study
- Treatment with csDMARDs (e.g., hydroxychloroquine, methotrexate) within 28 days before baseline or planned during the study
- Treatment with cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, azathioprine) within 28 days before baseline or planned during the study
- Treatment with JAK inhibitors (e.g., tofacitinib, baricitinib) within 28 days before baseline or planned during the study
- Treatment with BTK inhibitors (e.g., ibrutinib, zanubrutinib) within 28 days before baseline or planned during the study
- Treatment with certain biologic DMARDs (etanercept, adalimumab, anakinra) within 28 days before baseline or planned during the study
- Treatment with other biologic DMARDs (infliximab, rituximab, belimumab, etc.) within specified timeframes before baseline or planned during the study
- History or current inflammatory or autoimmune disease other than IgG4-related disease
- Active tuberculosis, HIV, or hepatitis B or C infection
- History of cancer except certain treated and cured cancers as specified
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304-2210
Actively Recruiting
Research Team
T
Travis Deal
CONTACT
A
Angie Aberia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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