Zanubrutinib in Patients With IgG4-Related Disease

Trial ID or NCT#

NCT04602598

Status

not recruiting iconNOT 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:
  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
  2. * 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)
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Investigator(s)

Matthew C. Baker, MD MS
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