NCT04602598

Zanubrutinib in Patients With IgG4-Related Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Matthew C. Baker · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IgG4 Related Disease

Interventions

Type	Name	Description
DRUG	Zanubrutinib 80 MG	Zanubrutinib 80 MG for 24 weeks

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-02-11
• Completion: 2025-04-03
• First posted: 2020-10-26
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study