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

Matthew C. Baker1 个研究点分布在 1 个国家目标入组 10 人2022年8月1日

适应症IgG4 Related Disease

干预措施Zanubrutinib 80 MG

概览

阶段: 2 期
干预措施: Zanubrutinib 80 MG
疾病 / 适应症: IgG4 Related Disease
发起方: Matthew C. Baker
入组人数: 10
试验地点: 1
主要终点: Volume of the Submandibular Glands on PET-MRI
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2022年8月1日

结束日期

2025年4月3日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Matthew C. Baker

责任方

Sponsor Investigator

主要研究者

Matthew C. Baker

Assistant Professor

Stanford University

入排标准

入选标准

•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

排除标准

•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)

研究组 & 干预措施

Zanubrutinib

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

干预措施: Zanubrutinib 80 MG

结局指标

主要结局

Volume of the Submandibular Glands on PET-MRI

时间窗: Baseline and 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

时间窗: Baseline and Week 24

To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.

次要结局

Change in Lacrimal Glands on MRI(Baseline, Week 12, and Week 24)
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)
Change in Parotid Glands on MRI(Baseline, Week 12, and Week 24)
Change in the Volume of the Parotid Glands on PET/MRI(Baseline, Week 12, and Week 24)
Change in the Volume of the Submandibular Glands on PET/MRI(Baseline and Week 12)
Change in the Volume of the Lacrimal Glands on PET/MRI(Baseline, and Week 12)
Change in Serum IgG4 Level(Baseline, Week 12, and Week 24)
Change in Plasmablast Count(Baseline, Week 12, and Week 24)
Change in Absolute Regulatory B Cell Count(Baseline, Week 12, and Week 24)
Change in the IgG4-RD Responder Index(Baseline, Week 12, and Week 24)
Proportion of Patients With no Disease Flares(Week 12 to Week 24)
Change in Total Salivary Grey Scale Ultrasound Score (TUS)(Baseline, Week 12, and Week 24)
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)(Baseline, Week 12, and Week 24)
Change in Total IgG Lab(Baseline, Week 12, and Week 24)
Change in Glandular Inflammation Total Ultrasound Score (iTUS)(Baseline, Week 12, and Week 24)
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)(Baseline, Week 12, and Week 24)
Change in Physician Global Assessment of Disease(Baseline, Week 12, and Week 24)
Change in Patient Global Assessment of Disease(Baseline, Week 12, and Week 24)
Change in VAS for Ocular Symptoms - Dryness(Baseline to Week 24)
Change in VAS for Dryness Symptoms(Baseline, Week 12, Week 24)
Change in FACIT-F Fatigue Score(Baseline, Week 12, and Week 24)
Change in RAND Short Form-36(Baseline, Week 12, and Week 24)
Change in C3 Lab(Baseline, Week 12, and Week 24)
Change in C4 Lab(Baseline, Week 12, and Week 24)
Change in IgE Lab(Baseline, Week 12, and Week 24)
Change in IgG1 Lab(Baseline, Week 12, and Week 24)
Change in ESR Lab(Baseline, Week 12, and Week 24)
Change in CRP Lab(Baseline, Week 12, and Week 24)
Incidence of Safety Parameters Including Adverse Events(Baseline to Week 32)
Incidence of Safety Parameters Including Abnormal Laboratory Results(Baseline to Week 32)