Zanubrutinib in Patients With IgG4-Related Disease

Phase 2

Active, not recruiting

• Conditions: IgG4 Related Disease
• Interventions: Drug: Zanubrutinib 80 MG

• Registration Number: NCT04602598
• Lead Sponsor: Matthew C. Baker

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Study Start: 2022-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-02-11
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zanubrutinib	Zanubrutinib 80 MG	Zanubrutinib orally at a dose of 80mg BID for 24 weeks

Primary Outcome Measures

Name	Time	Method
Volume of the lacrimal glands on PET-MRI	Baseline to Week 24	To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.
Volume of the submandibular glands on PET-MRI	Baseline to Week 24	To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at Week 24 compared to Baseline.

Secondary Outcome Measures

Name	Time	Method
FDG avidity (SUVmax) of the submandibular glands on PET-MRI	Baseline to Week 24	Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET-MRI at Week 24 compared to Baseline.
FDG avidity (SUVmax) of the lacrimal glands on PET-MRI	Baseline to Week 24	Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States