NCT06773403终止4 期
A 24 Week, Open-Label Study to Evaluate the Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Prurigo Nodularis
Psoriasis Treatment Center of Central New Jersey2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Reduction in worst-itch numeric rating scale (WI-NRS) at week 12
研究概览
简要总结
A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult 18-64 years of age at time of screening.
- •Diagnosis of prurigo nodularis for ≥ 3 months.
- •Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline .
- •Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
- •Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
- •If female, subject must be postmenopausal OR permanently surgically sterile OR for females of childbearing potential practicing at least one protocol specified method of birth control, that is effective from the Baseline Visit through at least 30 days after the last dose of study drug. Female subject must not be pregnant, breastfeeding or considering becoming pregnant during the study or for approximately 30 days after the last dose of the study drug.
- •Subject is a candidate for systemic therapy per investigator discretion.
- •Able and willing to give written informed consent prior to performance of any study-related procedures.
- •Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.
排除标准
- •Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments.
- •Diagnosis of active atopic dermatitis at screening and baseline.
- •PN secondary to medications.
- •PN secondary to medical conditions such as neuropathy or psychiatric disease.
- •Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study.
- •Severe renal conditions (eg, patients with uremia and/or on dialysis)
- •Participants with uncontrolled thyroid disease.
- •Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Patients with latent TB at screening may be enrolled if tuberculosis treatment is initiated prior to first dose.
- •Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
- •Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
- •Known or suspected immunodeficiency.
- •Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
研究组 & 干预措施
Upadacitinib
Other
Open-label use of 15mg upadacitinib. Subjects have the option to increase to 30mg at week 8 if the investigator deems it necessary.
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Reduction in worst-itch numeric rating scale (WI-NRS) at week 12
时间窗: 12 weeks
Proportion of participants with improvement (change) in worst-itch numeric rating scale (WI-NRS) by ≥4 points from baseline to Week 12.
次要结局
未报告次要终点
研究者
研究点 (2)
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