Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
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
- Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
研究概览
简要总结
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.
详细描述
This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week Screening period, a 12-week treatment period and then a 4-week follow up period. The arms will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of the 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or female participants between ages 18-80 years at time of signing informed consent
- •A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct anatomic locations)
- •Subject has ongoing chronic pruritus of unknown origin, which must be present on multiple segments on the body. CPUO patients must not have known dermatologic or systemic conditions, that in the opinion of the investigator, are the cause of patient's pruritus
- •Subject has moderate to severe pruritus, defined as average peak pruritus numeric rating scale - (PP-NRS) > 7 (range 0-10, higher score indicating greater degree of pruritus severity) in the 7 days prior to the Screening Visit.
- •Female participants are eligible for the study if they are not pregnant, planning to become pregnant or breastfeeding during the study or not a woman of child bearing potential (WOCBP)
排除标准
- •Infected with hepatitis B or hepatitis C viruses.
- •Infected with Herpes Simplex or Herpes zoster.
- •Positive HIV serology at screening,
- •Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- •History of lymphoproliferative disease, or active primary or recurrent malignancy
- •History of recurrent (≥ 2) venous thromboembolism (VTE) or (DVT/PE) - deep vein thrombosis and pulmonary embolism
- •Untreated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy
- •Have received any of the following treatment regiments specified in the timeframes outlined below:
- •Within 6 months of first dose of study drug: Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
- •Within 12 weeks of first dose of study drug: Any studies with Janus kinase (JAK) inhibitors; Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
- •Within 8 weeks of first dose of study drug: Other biologics
- •Within 6 weeks: Have been vaccinated with live or attenuated live vaccine.
- •Within 4 weeks: Participation in other studies involving investigational drug(s)
- •Within 4 weeks: Use of oral immune suppressants; systemic immunosuppressive therapies, neuromodulatory therapies, Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
- •Within 1 week of first dose of study drug: Topical treatments that could affect PN; Herbal medications with unknown properties or known beneficial effects for PN.
研究组 & 干预措施
Prurigo Nodularis
Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants).
干预措施: Abrocitinib (Drug)
Chronic Pruritus of Unknown Origin
Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants).
干预措施: Abrocitinib (Drug)
结局指标
主要结局
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
时间窗: Up to 12 weeks
Percent change in weekly average PP-NRS at Week 12. PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.
次要结局
- Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12(Up to 12 weeks)
- Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Number of Nodules at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Prurigo Nodule Severity at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Itch Intensity in CPUO Patients With High Eosinophilia at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12(Baseline (week 0) and 12 weeks)
- Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12(Baseline and 12 weeks)