NCT05702268招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Moderate-to-severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 28
- 主要终点
- Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for 4 weeks.
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
- •Male or female subjects aged ≥18 years and ≤75 years.
- •A clinical diagnosis of atopic dermatitis or eczema was made at least 1 year prior to D1, and atopic dermatitis was identified at screening visit (according to Williams criteria).
- •During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers.
- •Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy.
- •Able and willing to use an additive free mild emollient twice a day for at least 7 days prior to baseline and for the duration of the study.
- •The serum pregnancy test of all female subjects at screening visit was negative, and the urine pregnancy test of all fertile female subjects at baseline visit was negative before first dosing.
- •Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures.
- •Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Fertile women (WOCBP) menstruation must occur during the screening period and consent to use a supplementary screen contraceptive method in combination with a highly effective contraceptive method during the study period and for 90 days after the last use of the study drug .Male subjects must be willing not to donate sperm during this period.
排除标准
- •Pregnant female subjects and nursing female subjects.
- •Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD.
- •Current or previous infection history, including a history of herpes; Known history of invasive infection; Chronic recurrent infection and/or active invasive infection. Known immunodeficiency syndrome; Subjects with tuberculosis; Non skin related active infection.
- •Active HBV, HCV or HIV, syphilis infection.
- •Potential medical diseases or problems, including but not limited to the following: clinically relevant or significant ECG abnormalities; History of moderate to severe congestive heart failure, recent cerebrovascular accident, myocardial infarction or coronary stent implantation, or uncontrolled hypertension; Have received organ transplantation; A history of gastrointestinal perforation, diverticulitis, or a significant increased risk of gastrointestinal perforation according to the investigator's judgment; Diseases that may interfere with drug absorption; Subjects suffering from any malignant tumor before screening.
- •Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases.
- •Received the specified treatment plan within the specified time frame.
- •The time from the last use of powerful CYP3A inhibitor or inducer to the first trial medication is less than 5 clearance half-life, or it is planned to take powerful CYP3A inhibitor or inducer at the same time during this study.
- •Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator).
- •During the screening period before the first administration of the study drug (baseline visit), the abnormal laboratory values met at least one of the specified standards.
- •The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.
研究组 & 干预措施
High-dose
Experimental
40 mg ICP-332 tablet 3 tablets, once a day
干预措施: ICP-332 (Drug)
Low-dose
Experimental
40 mg ICP-332 2 tablets + 1 placebo tablet once daily
干预措施: ICP-332 (Drug)
Low-dose
Experimental
40 mg ICP-332 2 tablets + 1 placebo tablet once daily
干预措施: ICP-332 Placebo (Drug)
Blank control
Placebo Comparator
Placebo 3 tablets once daily
干预措施: ICP-332 Placebo (Drug)
结局指标
主要结局
Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0
时间窗: Up to 24 weeks
Systolic and Diastolic Blood Pressure
时间窗: Up to 24 weeks
Pulse Rate
时间窗: Up to 24 weeks
Adverse events (AEs)
时间窗: Up to 24 weeks
Electrocardiogram (ECG) QT Interval
时间窗: Up to 24 weeks
次要结局
- Percentage change of EASI score from baseline in week 4(4 weeks)
研究者
研究点 (28)
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