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New treatment option for IgG4-related Disease
Official title A Study of Efgartigimod in Patients With IgG4-Related Disease
ClinicalTrials.gov ID: NCT07025330
What this study is testing
What is Efgartigimod?
Efgartigimod is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for igg4-related disease.
Also referred to as efgartigimod alfa and hyaluronidase-qvfc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
You likely can't join if
- 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...
- Treatment with cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine...
See the full eligibility criteria
- 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 Key
- 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 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...
- 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 how well it works 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...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.