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IgG4-related DiseasePhase 2NCT07025330

A Study of Efgartigimod in Patients With IgG4-Related Disease

A Phase 2 study testing Efgartigimod in people with IgG4-related Disease, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
IgG4-related Disease
What is being tested?
Efgartigimod
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
12 Nov 2025to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Any exclusion criteria listed in the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease
  • Prior treatment with an FcRn inhibitor
  • Have conventional synthetic disease-modifying antirheumatic drug (csDMARD) or immunosuppressive use as follows:
  • 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
  • Treatment with cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to Baseline or planned treatment during the study
Show all 19Show fewer
  • Treatment with a janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, upadacitinib, or filgotinib within 28 days prior to Baseline or planned treatment during the study
  • Treatment with a Bruton's tyrosine kinase (BTK) inhibitor including but not limited to ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib, or rilzabrutinib within 28 days prior to Baseline or planned treatment during the study
  • Have biologic disease-modifying antirheumatic drug (bDMARD) use as follows:
  • Treatment with etanercept, adalimumab, or anakinra within 28 days before Baseline or planned treatment during the study
  • Treatment with infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab within 56 days before Baseline or planned treatment during the study
  • Treatment with a B cell depleting agent including but not limited to rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab, or obexelimab ≤ 6 months prior to Baseline
  • Patients who received B-cell targeted therapy > 6 and ≤ 12 months prior to Baseline must have a B-cell count that is within the laboratory reference range at Screening
  • Treatment with a BAFF antagonist including but not limited to belimumab or tabalumab within 6 months before Baseline or planned treatment during the study
  • Treatment with an IL-17 antagonist including but not limited to secukinumab, ixekizumab, or brodalumab within 6 months before Baseline or planned treatment during the study
  • Prior treatment with other bDMARDs may be allowed at the discretion of the investigator
  • A history of, or current, inflammatory or autoimmune disease (that could affect the interpretation of safety or efficacy outcomes) other than IgG4-related disease
  • Evidence of active tuberculosis, HIV, or hepatitis B or C infection
  • History of cancer except for skin basal or squamous cell carcinoma, cervical dysplasia or carcinoma in situ that has been treated and is considered cured > 1 year prior to Baseline, prostate cancer considered cured for > 5 years with a normal prostate specific antigen, or colon cancer considered cured > 5 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94304-2210

Other trials in United States

About this study

Official title: 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
Being tested
Efgartigimod
Keywords
efgartigimod, IgG4-RD, IgG4-related disease, FcRn, FcRn inhibitor
Medical subject headings
Immunoglobulin G4-Related Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfgartigimodDrug

    Also called efgartigimod alfa and hyaluronidase-qvfc

    efgartigimod 1000 mg subcutaneous injection given once weekly

Study groups in NCT07025330
Study groupRoleWhat they receive
efgartigimodExperimentalParticipants will be treated with efgartigimod 1000 mg subcutaneously once weekly for up to 12 weeks
Receives: Drug: Efgartigimod

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: From Baseline to Week 12

  3. Change in volume of pancreas on FDG-PET/MRI

    Measured: From Baseline to Week 12

Secondary outcomes (37)

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

    Measured: Baseline to Week 12

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

    Measured: 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

    Measured: Baseline to Week 12

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

    Measured: Baseline to Week 12

  5. Change in FDG avidity (SUVmean) of salivary glands on PET

    Measured: Baseline to Week 12

  6. Change in FDG avidity (total gland glycolysis) of salivary glands on PET

    Total gland glycolysis is SUVmean x gland volume

    Measured: Baseline to Week 12

  7. Change in FDG avidity (SUVmax) of pancreas on PET

    Measured: Baseline to Week 12

  8. Change in FDG avidity (SUVmean) of pancreas on PET

    Measured: Baseline to Week 12

  9. Change in FDG avidity (total pancreatic glycolysis) of pancreas on PET

    Total pancreatic glycolysis is SUVmean x pancreatic volume

    Measured: Baseline to Week 12

  10. Change in exchange transfer (K^trans) of lacrimal glands on MRI

    Measured: From Baseline to Week 12

  11. Change in apparent diffusion coefficient (ADC) of lacrimal glands on MRI

    Measured: From Baseline to Week 12

  12. Change in microvascular volume fraction (f) of lacrimal glands on MRI

    Measured: From Baseline to Week 12

  13. Change in exchange transfer (K^trans) of salivary glands on MRI

    Measured: From Baseline to Week 12

  14. Change in apparent diffusion coefficient (ADC) of salivary glands on MRI

    Measured: From Baseline to Week 12

  15. Change in microvascular volume fraction (f) of salivary glands on MRI

    Measured: From Baseline to Week 12

  16. Change in apparent diffusion coefficient (ADC) of pancreas on MRI

    Measured: From Baseline to Week 12

  17. Change in T1 mapping of pancreas on MRI

    Measured: From Baseline to Week 12

  18. Change in T2 mapping of pancreas on MRI

    Measured: From Baseline to Week 12

  19. Change in extracellular volume (ECV) of pancreas on MRI

    Measured: From Baseline to Week 12

  20. Change in microvascular perfusion fraction of pancreas on MRI

    Measured: From Baseline to Week 12

  21. Change in serum IgG4 level

    Measured: From Baseline to Week 12

  22. Change in serum IgG level

    Measured: From Baseline to Week 12

  23. Change in serum IgE level

    Measured: From Baseline to Week 12

  24. Change in plasmablast count

    Measured: From Baseline to Week 12

  25. Change in absolute regulatory B cell count

    Measured: From Baseline to Week 12

  26. Change in IgG4-RD Responder Index

    Measured: From Baseline to Week 12

  27. Change in physician global assessment of disease

    Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.

    Measured: From Baseline to Week 12

  28. Change in patient global assessment of disease

    Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.

    Measured: From Baseline to Week 12

  29. Change in patient global assessment of ocular symptoms

    Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.

    Measured: From Baseline to Week 12

  30. Change in patient global assessment of salivary symptoms

    Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.

    Measured: From Baseline to Week 12

  31. Change in FACIT-F fatigue score

    Total score range: 0-52, lower scores correspond with more fatigue.

    Measured: From Baseline to Week 12

  32. Change in C3 laboratory assessment

    Measured: From Baseline to Week 12

  33. Change in C4 laboratory assessment

    Measured: From Baseline to Week 12

  34. Change in total IgG laboratory assessment

    Measured: From Baseline to Week 12

  35. Change in ESR laboratory assessment

    Measured: From Baseline to Week 12

  36. Change in CRP laboratory assessment

    Measured: From Baseline to Week 12

  37. Number of participants with safety endpoints of interest

    Safety endpoints of interest include hypogammaglobulinemia, severe infection requiring hospitalization or IV antibiotics, and mortality

    Measured: From Screening to end of follow-up at Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start12 Nov 2025
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025330
Sponsor's protocol ID
79851
Status last verified
Jul 2026
First submitted
9 Jun 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efgartigimod in people with IgG4-related Disease, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in volume on FDG-PET/MRI of lacrimal gland(s) and/or (time frame: From Baseline to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07025330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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