Zanubrutinib in Patients With IgG4-Related Disease
Primary Purpose
IgG4 Related Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zanubrutinib 80 MG
Sponsored by
About this trial
This is an interventional treatment trial for IgG4 Related Disease
Eligibility 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)
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zanubrutinib
Arm Description
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04602598
First Posted
October 20, 2020
Last Updated
October 24, 2022
Sponsor
Matthew C. Baker
Collaborators
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT04602598
Brief Title
Zanubrutinib in Patients With IgG4-Related Disease
Official Title
A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew C. Baker
Collaborators
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4 Related Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zanubrutinib
Arm Type
Experimental
Arm Description
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib 80 MG
Intervention Description
Zanubrutinib 80 MG for 24 weeks
Primary Outcome Measure Information:
Title
Volume of the submandibular glands on PET-MRI
Description
To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at Week 24 compared to Baseline.
Time Frame
Baseline to Week 24
Title
Volume of the lacrimal glands on PET-MRI
Description
To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
FDG avidity (SUVmax) of the submandibular glands on PET-MRI
Description
Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET-MRI at Week 24 compared to Baseline.
Time Frame
Baseline to Week 24
Title
FDG avidity (SUVmax) of the lacrimal glands on PET-MRI
Description
Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew C Baker, MD
Phone
650-497-0774
Email
mbaker13@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angie R Aberia, BA
Phone
650-723-8516
Email
aaberia@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew C Baker, MD, MS
First Name & Middle Initial & Last Name & Degree
Matthew C Baker, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Zanubrutinib in Patients With IgG4-Related Disease
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