An Efficacy and Safety Study of JYP0061 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are:
- The efficacy of JYP0061 in treating adult patients with moderate-to-severe atopic dermatitis.
- The safety profile of JYP0061 when administered to adult patients with moderate-to-severe atopic dermatitis.
Participants will:
- Be treated with either a low-dose or high-dose of JYP0061.
- Undergo efficacy and safety evaluations as stipulated in the trial protocol.
详细描述
The goal of this clinical trial is to assess JYP0061 for efficacy and safety in adult patients with moderate-to-severe atopic dermatitis. The main objectives it aims to address are the determination of the drug's therapeutic effect and its safety profile in this patient population. Upon providing written informed consent after being briefed on the study details and potential risks, participants will enter a screening period of up to 4 weeks to confirm their eligibility.
The main tasks for participants will include:
- Being randomized to receive either a low-dose or high-dose of JYP0061.
- Completing a treatment course of 12 weeks.
- Undergoing efficacy and safety assessments as prescribed by the study's protocol.
Following the treatment phase, all participants, whether they have completed the treatment course on schedule or have discontinued early, will be monitored for an additional 4 weeks to further evaluate safety post-treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the participants should be between 18 and 65 years old, with no restrictions on gender.
- •Participants must weigh 40 kg or more
- •At the time of screening, participants must meet the Williams criteria for atopic dermatitis, have had the condition for at least one year, and the severity of the disease should be moderate to severe;
- •Participants agree from the time of signing the informed consent form until the completion of the study's final visit to use only non-medicated emollients (moisturizing creams) or other concomitant treatments allowed by the protocol.
- •Fully understand the purpose and requirements of this trial, voluntarily participate, and sign the written informed consent form, and are able to complete the study according to its requirements.
排除标准
- •Suspected or confirmed allergy to any component of the study drug or similar ingredients, or having a history of moderate allergic diseases (such as food allergies, drug allergies, etc., except for allergies related to atopic dermatitis) at the time of signing the informed consent form;
- •At the time of screening, having other skin diseases or skin infections that could affect the evaluation of the trial results, or having extensive tattoos, birthmarks, skin scars, etc., in the area of skin lesions, aside from atopic dermatitis;
- •Having or having had other connective tissue diseases, apart from a history of atopic dermatitis;
- •Participation in another clinical trial within one month prior to screening or within five half-lives of the investigational drug (whichever is longer);
- •Underwent major surgery within 12 weeks prior to screening;
- •Conditions that negatively affect the immune response (such as history of organ transplantation), or subjects with known immunodeficiency syndromes (acquired immunodeficiency syndrome, genetic immunodeficiency, and drug-induced immunodeficiency).
研究组 & 干预措施
JYP0061 15 mg Group
Participants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks.
干预措施: JYP0061 15 mg (Drug)
JYP0061 30 mg Group
articipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 12 weeks.
干预措施: JYP0061 30 mg (Drug)
Placebo Group
Participants in this arm will receive a placebo once daily for a total treatment period of 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.
时间窗: Evaluations will be conducted weekly for up to 12 weeks
The Eczema Area and Severity Index (EASI) is a measure of eczema severity, combining area coverage and symptom intensity (erythema, edema/papulation, excoriation, lichenification) for four body regions. EASI scores range from 0 (no eczema) to 72 (maximum severity), with higher scores indicating worse outcomes. This primary outcome assesses the proportion of participants who achieve at least a 75% reduction in EASI from baseline to Week 12.
次要结局
- Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.(Weeks 2, 4, and 8.)