Zanubrutinib in Patients With IgG4-Related Disease

Exclusion Criteria

• •Unstable prescribed dose of glucocorticoids within 28 days prior to baseline
• •Any treatment with a synthetic DMARD including but not limited to hydroxychloroquine, methotrexate, leflunomide, or sulfasalazine within 28 days prior to baseline
• •Any treatment with a cytotoxic or immunosuppressive drug including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to baseline
• •Any treatment with a BTK inhibitor within 6 months before baseline
• •Any treatment with a JAK inhibitor within 28 days prior to baseline
• •Use of biologic agents including infliximab, abatacept, or tocilizumab within 56 days prior to baseline
• •Use of a B cell depleting therapy (such as rituximab) within 12 months prior to baseline
• •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 other than non-melanoma skin cancer, cervical dysplasia or carcinoma in situ (cured \>1 year), prostate cancer (cured \>5 years), or colon cancer (cured \>5 years)