An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Week 4 evaluation
研究概览
简要总结
A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.
详细描述
Sample size: 20 patients Study duration: 16 weeks
Primary Endpoints:
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to Baseline.
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline.
Secondary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI
排除标准
- •Uncontrolled hypertension (systolic blood pressure [BP] ≥135 mmHg and/or diastolic BP ≥85 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening.
- •History of myocardial infarction within 3 months prior to screening.
- •Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization.
- •Renal function impairment with creatinine clearance <30 mL/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation).
- •Liver function impairment with aspartate aminotransferase/alanine aminotransferase >=3x the upper limit of normal or bilirubin >2X the upper limit of normal at screening.
- •Neutrophil count <1000/µL at screening.
- •History of an allergic reaction or hypersensitivity to the study treatment or any component of the study treatment formulation.
- •Has documented HIV infection or documented, active hepatitis B or hepatitis C infection.
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- •Individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer).
- •Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
研究组 & 干预措施
Open Label Fostamatinib
Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1
干预措施: Fostamatinib (Drug)
结局指标
主要结局
Week 4 evaluation
时间窗: 4 weeks
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Week 12 evaluation
时间窗: 12 weeks
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
次要结局
- Abscess and Nodule Count Week 4(4 weeks)
- Physician Rated Overall Disease Severity(12 weeks)
- International Hidradenitis Suppurativa Severity Score (IHS4) Week 12(12 weeks)
- International Hidradenitis Suppurativa Severity Score (IHS4) Week 4(4 weeks)
- Grade 2/3 Adverse Events(12 weeks)
- Abscess and Nodule count week 12(12 weeks)
- Dermatology Life Quality Index (DLQI)(12 weeks)
研究者
John Frew
Principal Investigator
Holdsworth House Medical Practice