Zanubrutinib in Patients With IgG4-Related Disease
Trial ID or NCT#
NCT04602598
Status
RECRUITING
Purpose
The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease
Official Title
A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease
Eligibility Criteria
Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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)
Investigator(s)
Matthew C. Baker, MD MS
Immunologist,
Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)
Kip E. Guja, MD PhD
Clinical Instructor, Radiology - Rad/Nuclear Medicine
Contact us to find out if this trial is right for you.
Contact
Angie Aberia
650-723-8516
View on ClinicalTrials.gov
