A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 69
- 试验地点
- 5
- 主要终点
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- •Have a PGA score of 2 (mild) or 3 (moderate) at Day
- •Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day
- •At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).
排除标准
- •Evidence of certain skin conditions/infections at baseline
- •Currently have atopic dermatitis on groin, genitals, palm or soles
- •Have certain laboratory abnormalities at baseline
- •Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
研究组 & 干预措施
Treatment B
干预措施: Placebo ointment (Vehicle) (Drug)
Treatment group A
干预措施: Tofacitinib ointment 20mg/g (Drug)
结局指标
主要结局
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
时间窗: Baseline (pre-dose on Day 1) and Week 4
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
次要结局
- Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4(Week 4)
- Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4(Baseline (pre-dose on Day 1) and Week 4)
- Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4(Baseline (pre-dose on Day 1) and Week 4)
- Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4(Baseline (pre-dose on Day 1) and Week 4)