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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Efgartigimod

    Drug

    efgartigimod 1000 mg subcutaneous injection given once weekly

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: efgartigimodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From Baseline to Week 12
2

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

Salivary glands include parotid glands, submandibular glands, sublingual glands

Time frame
From Baseline to Week 12
3

Change in volume of pancreas on FDG-PET/MRI

Time frame
From Baseline to Week 12

Secondary outcomes

1

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

Time frame
Baseline to Week 12
2

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

Time frame
Baseline to Week 12
3

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

Total gland glycolysis is SUVmean x gland volume

Time frame
Baseline to Week 12
4

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

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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