NCT05399368终止2 期
A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With 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
- 终止
- 入组人数
- 229
- 试验地点
- 59
- 主要终点
- To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
研究概览
简要总结
Phase 2 study of RPT193 in adults with atopic dermatitis
详细描述
Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind
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
- •Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
- •12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
- •inadequate response to a ≥1 month treatment with topical medications
- •Atopic dermatitis covering ≥10% of the body surface area
- •EASI score ≥16
- •Validated Investigator Global Assessment (VIGA) ≥3
- •Use of emollient(s) at least 2x daily for 1 week prior to baseline
- •Negative coronavirus disease (COVID)-19 results at screening
排除标准
- •Uncontrolled moderate-to-severe asthma
- •Uncontrolled diabetes
- •Stage III or IV cardiac failure
- •Severe renal condition
- •Major surgery within 8 weeks of screening
- •Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
- •Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
- •Received live or live-attenuated vaccine within 4 weeks of baseline
- •Prior receipt of RPT193
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo oral tablet administered daily for 16 weeks
干预措施: Placebo (Other)
RPT193 400 mg
Experimental
RPT193 400 mg oral tablet administered daily for 16 weeks
干预措施: RPT193 (Drug)
RPT193 200 mg
Experimental
RPT193 200 mg oral tablet administered daily for 16 weeks
干预措施: RPT193 (Drug)
RPT193 50 mg
Experimental
RPT193 50 mg oral tablet administered daily for 16 weeks
干预措施: RPT193 (Drug)
结局指标
主要结局
To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
时间窗: 16 weeks
% change in Eczema Area Severity Index (EASI) from baseline at Week 16
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(16 weeks)
研究者
研究点 (59)
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