Actively Recruiting
A Phase IIa, Open-Label Study of Efgartigimod for Adults With IgG4-Related Disease
Led by Stanford University · Updated on 2026-02-10
5
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating efgartigimod as a potential treatment for adults with IgG4-related disease. This Phase IIa, open-label study focuses on whether efgartigimod can reduce the volume of affected lacrimal glands, salivary glands, and/or pancreas. The main goal is to understand the impact of this treatment on these organs in patients with this condition. Participants will receive 1000 mg of efgartigimod by subcutaneous injection once a week for up to 12 weeks. During this time, they will have clinic visits every one to six weeks for checkups and tests. The treatment period aims to assess changes in gland and pancreas volume as well as other disease-related markers. Throughout the study, participants will complete questionnaires about their symptoms and overall health while undergoing imaging tests like FDG-PET and MRI scans to measure changes in affected organs. Researchers will also monitor blood markers and assess safety over 18 weeks, including follow-up visits. The study duration allows careful observation of treatment effects and participant well-being.
CONDITIONS
Brief 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 level at least twice the upper limit of normal at screening
- Involvement of lacrimal glands, salivary glands, and/or pancreas
- Symptomatic lacrimal or salivary gland involvement (discomfort, pain, dryness, headache, or vision changes)
- Asymptomatic pancreatic involvement 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
- Recent or planned use of glucocorticoids within 28 days before baseline or during the study
- Recent or planned use of csDMARDs (e.g., hydroxychloroquine, methotrexate) within 28 days before baseline or during the study
- Recent or planned use of cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, azathioprine) within 28 days before baseline or during the study
- Recent or planned use of JAK inhibitors (e.g., tofacitinib, baricitinib) within 28 days before baseline or during the study
- Recent or planned use of BTK inhibitors (e.g., ibrutinib) within 28 days before baseline or during the study
- Recent or planned use of certain biologics (etanercept, adalimumab, anakinra) within 28 days before baseline or during the study
- Recent or planned use of other biologics (infliximab, abatacept, tocilizumab) within 56 days before baseline or during the study
- B cell depleting therapy within 6 months before baseline
- B cell targeted therapy 6 to 12 months prior must have normal B-cell count at screening
- Recent or planned use of BAFF antagonists (e.g., belimumab) within 6 months before baseline or during the study
- Recent or planned use of IL-17 antagonists (e.g., secukinumab) within 6 months before baseline or during the study
- History or current inflammatory or autoimmune diseases other than IgG4-related disease
- Active tuberculosis, HIV, or hepatitis B or C infection
- History of cancer except certain treated and cured types as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive efgartigimod 1000 mg as a subcutaneous injection once weekly for up to 12 weeks.
Weekly visits for up to 12 weeks
Duration - 6 weeks
Participants are monitored for safety and response after completing treatment.
1 to 2 visits during follow-up
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304-2210
Actively Recruiting
Research Team
T
Travis Deal
A
Angie Aberia
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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