A Phase IIa, Single-Site, Open-Label Study of Efgartigimod in Patients With IgG4-Related Disease
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
• 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