A Study of Efgartigimod in Patients With IgG4-Related Disease

ConditionIgG4-related Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-90

SponsorStanford University

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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 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

Trial design

Treatments tested in this trial

Efgartigimod

Treatment groups

5 Participants

are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

Source ClinicalTrials.gov