NCT07236099招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 45
- 主要终点
- Peak pruritus-numeric rate scale (PP NRS)
研究概览
简要总结
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
- •Male or female aged between 18 and 75 years at the time of signing the informed consent.
- •Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
- •At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
- •PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
- •IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
- •History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- •Willingness to avoid pregnancy or fathering children
排除标准
- •Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
- •Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ICP-332 80mg
Experimental
干预措施: ICP-322 (Drug)
ICP-332 120mg
Experimental
干预措施: ICP-322 (Drug)
结局指标
主要结局
Peak pruritus-numeric rate scale (PP NRS)
时间窗: Baseline to week 16
Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16. Participants will be asked to rate their itch at the worst moment during the previous 24 hours. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Baseline through week 40)
- Improvement in PP NRS score(Baseline through week 40)
- Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)(Baseline through week 40)
- Dermatology Life Quality Index (DLQI)(Baseline through week 40)
- Maximum concentration (Cmax)(Baseline through week 40)
- Area Under Concentration Versus Time Curve (AUC)(Baseline through week 40)
研究者
研究点 (45)
Loading locations...
相似试验
进行中（未招募）
2 期
ICP-332 在结节性痒疹受试者中的有效性和安全性CTR2025428555
尚未招募
2 期
A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal WomenVasomotor SymptomsNCT06393673Hansoh BioMedical R&D Company195
招募中
2 期
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19SARS-CoV-2 InfectionNCT05633433Shanghai Henlius Biotech1,550
已完成
2 期
A Phase 2b Diabetic Kidney Disease StudyDiabetic Kidney DiseaseNCT04170543AstraZeneca609
进行中（未招募）
2 期
A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 PatientsMild to Moderate COVID-19NCT05941793Oneness Biotech Co., Ltd.135