Zanubrutinib in Patients With IgG4-Related Disease

IgG4 Related Disease Clinical Trial

Official title:

A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602598
• Other study ID #: 58497
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Matthew C Baker, MD
• Phone: 650-497-0774
• Email: mbaker13[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease

Description:

This will be a single-site, open-label study in symptomatic patients with IgG4-related disease affecting the submandibular and/or lacrimal glands. All patients will receive zanubrutinib orally at a dose of 80mg BID for 24 weeks.

The primary objective of this study is to demonstrate that zanubrutinib treatment reduces reduces the volume of the submandibular and/or lacrimal glands on PET/MRI at week 24 compared to baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• IgG4 Related Disease

Intervention

Drug:
• Zanubrutinib 80 MG
Zanubrutinib 80 MG for 24 weeks

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Matthew C. Baker	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of the submandibular glands on PET-MRI	To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at Week 24 compared to Baseline.	Baseline to Week 24
Primary	Volume of the lacrimal glands on PET-MRI	To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.	Baseline to Week 24
Secondary	FDG avidity (SUVmax) of the submandibular glands on PET-MRI	Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET-MRI at Week 24 compared to Baseline.	Baseline to Week 24
Secondary	FDG avidity (SUVmax) of the lacrimal glands on PET-MRI	Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.	Baseline to Week 24