Zanubrutinib in Patients With IgG4-Related Disease

Trial ID or NCT#

NCT04602598

Status

recruiting iconRECRUITING

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:
  1. - 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:
  1. - 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
Matthew C. Baker, MD MS
Immunologist, Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)

Contact us to find out if this trial is right for you.

Contact

Angie Aberia
650-723-8516