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Zanubrutinib in Patients With IgG4-Related Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602598
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : May 9, 2022
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Matthew C. Baker, Stanford University

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

Condition or disease Intervention/treatment Phase
IgG4 Related Disease Drug: Zanubrutinib 80 MG Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
 Drug: Zanubrutinib 80 MG
Zanubrutinib 80 MG for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Volume of the submandibular glands on PET-MRI [ Time Frame: 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.

  2. Volume of the lacrimal glands on PET-MRI [ Time Frame: 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.


Secondary Outcome Measures :
  1. FDG avidity (SUVmax) of the submandibular glands on PET-MRI [ Time Frame: 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.

  2. FDG avidity (SUVmax) of the lacrimal glands on PET-MRI [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602598


Contacts
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Contact: Matthew C Baker, MD 650-497-0774 mbaker13@stanford.edu
Contact: Angie R Aberia, BA 650-723-8516 aaberia@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Matthew C Baker, MD, MS         
Principal Investigator: Matthew C Baker, MD, MS         
Sponsors and Collaborators
Matthew C. Baker
Stanford University
More Information
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Responsible Party: Matthew C. Baker, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04602598    
Other Study ID Numbers: 58497
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases
Zanubrutinib
 Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action