Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Peak Pruritus Numerical Rating Score (PRNS)
研究概览
简要总结
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
详细描述
This is a 22-week (2 week screening, 18-week treatment period followed by a 2 week followup), phase II, open label, exploratory study to investigate the potential efficacy of FDA approved dupilumab in the treatment of adults with moderate to severe chronic hepatic pruritus. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment and follow-up for the next 20 weeks. A final visit will be needed for evaluation and questionnaire completion.
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
- •Male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. Chronic is defined as greater than 6 weeks of symptom duration. Pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity).
- •Documentation of a personally signed and dated informed consent indicating that the subject or their legally acceptable representative has been informed of all pertinent aspects of the trial.
- •Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures.
排除标准
- •Male and/or female subjects under 18 years of age.
- •Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.
- •Pregnant females
- •History of intrahepatic cholestasis of pregnancy
- •Any form of chronic hepatic pruritus associated with underlying malignancy
- •Liver transplant recipients
- •Allergy to dupilumab or its ingredients
- •Inability to provide informed consent
- •Concomitant use of selective opioid antagonists
- •Subjects with severe asthma (requiring high-dose inhaled or systemic corticosteroids) will be excluded from the study.
- •Patients with known helminth infections
研究组 & 干预措施
Dupilumab
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
干预措施: Dupilumab 300Mg Solution for Injection (Drug)
结局指标
主要结局
Change in Peak Pruritus Numerical Rating Score (PRNS)
时间窗: Baseline; 20 weeks
Pruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "On a scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Measured before and after treatment. Scores range from 0 to 10 with higher scores indicating a worse outcome.
次要结局
- Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline(Baseline; week 6,12,18)
- Verbal Rating Scale (VRS) Score(Baseline; week 12,18)
- Change in 5D Pruritus Score(Baseline; 18 Weeks)
- Change in Chronic Liver Disease Questionnaire (CLDQ) Score(Baseline; 18 Weeks)
研究者
Jason Sluzevich MD
Principal Investigator
Mayo Clinic