A Study of Efgartigimod in Patients With IgG4-Related Disease

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07025330
Phase
PHASE2
Status
Recruiting

Conditions

  • IgG4-related Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — DRUG
    efgartigimod 1000 mg subcutaneous injection given once weekly

Study Details

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

Key Dates

Start date
Nov 12, 2025
Status verified
Feb 2026
Primary completion
Mar 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod
    Participants will be treated with efgartigimod 1000 mg subcutaneously once weekly for up to 12 weeks

Primary Outcome Measure

Change in volume on FDG-PET/MRI of lacrimal gland(s) and/or [ Time Frame: From Baseline to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-2210
Travis Deal
650-723-7416
Matthew C Baker, MD, MS (PRINCIPAL_INVESTIGATOR)

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