Zanubrutinib in Patients With IgG4-Related Disease

Sponsor

Matthew C. Baker (Other)

Overall Status

Recruiting

CT.gov ID

NCT04602598

Collaborator

Stanford University (Other)

Enrollment

Location

Arm

32.1

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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

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

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

Matthew C. Baker
Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthew C. Baker, Clinical Assistant Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT04602598

Other Study ID Numbers:

58497

First Posted:

Oct 26, 2020

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Immunoglobulin G4-Related Disease

Zanubrutinib

Study Results

No Results Posted as of May 9, 2022