Zanubrutinib in Patients With IgG4-Related Disease
- Conditions
- IgG4 Related Disease
- Registration Number
- NCT04602598
- Lead Sponsor
- Matthew C. Baker
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> - Men or women aged 18 to 85, inclusive, at the time of initial screening<br><br> - Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the<br> lacrimal gland confirmed by international consensus pathology criteria<br><br> - Presence of a lymphoplasmacytic infiltrate with 10 IgG4+ plasma cells per<br> high-power field and/or an IgG4+/IgG+ plasma cell ratio of 40%<br><br> - All women must test negative for pregnancy and agree to use a reliable method of<br> birth control<br><br> - No current treatment with immunosuppressive medications other than prednisone 40mg<br> daily (or other glucocorticoid equivalent) with stable dosing for 28 days<br><br>Exclusion Criteria:<br><br> - Unstable prescribed dose of glucocorticoids within 28 days prior to baseline<br><br> - Any treatment with a synthetic DMARD including but not limited to<br> hydroxychloroquine, methotrexate, leflunomide, or sulfasalazine within 28 days prior<br> to baseline<br><br> - Any treatment with a cytotoxic or immunosuppressive drug including but not limited<br> to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or<br> tacrolimus within 28 days prior to baseline<br><br> - Any treatment with a BTK inhibitor within 6 months before baseline<br><br> - Any treatment with a JAK inhibitor within 28 days prior to baseline<br><br> - Use of biologic agents including infliximab, abatacept, or tocilizumab within 56<br> days prior to baseline<br><br> - Use of a B cell depleting therapy (such as rituximab) within 12 months prior to<br> baseline<br><br> - A history of, or current, inflammatory or autoimmune disease (that could affect the<br> interpretation of safety or efficacy outcomes) other than IgG4-related disease<br><br> - Evidence of active tuberculosis, HIV, or hepatitis B or C infection<br><br> - History of cancer other than non-melanoma skin cancer, cervical dysplasia or<br> carcinoma in situ (cured >1 year), prostate cancer (cured >5 years), or colon cancer<br> (cured >5 years)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume of the submandibular glands on PET-MRI;Volume of the lacrimal glands on PET-MRI
- Secondary Outcome Measures
Name Time Method FDG avidity (SUVmax) of the submandibular glands on PET-MRI;FDG avidity (SUVmax) of the lacrimal glands on PET-MRI