Zanubrutinib in Patients With IgG4-Related Disease

NCT04602598 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 58497
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgG4 Related Disease

Outcome Measures

Primary Outcomes (2)

• 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 and Week 24

• 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 and Week 24

Secondary Outcomes (34)

• FDG Avidity (SUVmax) of the Submandibular Glands on PET

  Baseline, Week 12, and Week 24

• FDG Avidity (SUVmax) of the Lacrimal Glands on PET

  Baseline, Week 12, and Week 24

• Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET

  Baseline, Week 12, and Week 24

• Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET

  Baseline, Week 12, and Week 24

• Change in Submandibular Glands on MRI

  Baseline, Week 12, and Week 24

Study Arms (1)

Zanubrutinib

EXPERIMENTAL

Zanubrutinib orally at a dose of 80mg BID for 24 weeks

Drug: Zanubrutinib 80 MG

Interventions

Zanubrutinib 80 MG DRUG

Zanubrutinib 80 MG for 24 weeks

Zanubrutinib

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Matthew C. Baker: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Matthew Baker
• Organization: Stanford University, School of Medicine, Division of Immunology & Rheumatology

mbake13@stanford.edu

6504970744

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open-label study in symptomatic subjects with histopathologically confirmed IgG4-related disease affecting the submandibular and/or lacrimal glands. Ten subjects will be included in the study. All eligible subjects will receive zanubrutinib 80mg BID over a period of 24 weeks and will be followed up for an additional 8 weeks after the last dose.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: August 1, 2022
• Primary Completion: February 11, 2025
• Study Completion: April 3, 2025
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)