Zanubrutinib in Patients With IgG4-Related Disease

Inclusion Criteria: * Men or women aged 18 to 85, inclusive, at the time of initial screening * Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the lacrimal gland confirmed by international consensus pathology criteria * Presence of a lymphoplasmacytic infiltrate with 10 IgG4+ plasma cells per high-power field and/or an IgG4+/IgG+ plasma cell ratio of 40% * All women must test negative for pregnancy and agree to use a reliable method of birth control * No current treatment with immunosuppressive medications other than prednisone 40mg daily (or other glucocorticoid equivalent) with stable dosing for 28 days 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…