A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)
概览
- 阶段
- 2 期
- 干预措施
- HY209GEL Active
- 疾病 / 适应症
- Atopic Dermatitis
- 发起方
- Shaperon
- 入组人数
- 210
- 试验地点
- 12
- 主要终点
- Percentage change in Eczema Area and Severity Index (EASI) score
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.
详细描述
Part 1 (2 cohorts): Total 33 subjects * Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) * Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) * Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects * Low dose of HY209gel: 59 subjects * High dose of HY209gel: 59 subjects * Placebo (Vehicle): 59 subjects Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe. Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.
研究者
入排标准
入选标准
- •Male or female subjects aged 18 or older
- •Subjects who have a history of AD at least 6 months ago from screening and have been clinically stable for ≥ 1 month
- •Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
- •Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits
- •Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit
- •Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation
排除标准
- •Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids
- •Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed)
- •Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit
- •Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit
- •Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit
- •Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening
- •Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer
- •Subjects who have any other skin diseases that would affect the ability to assess the AD
- •Subjects who are taking any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment
- •Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc
研究组 & 干预措施
PART 2 High-Dose
Active group selected for PART1 as a high-dose
干预措施: HY209GEL Active
PART 2 Low-Dose
Active group selected for PART1 as a Low-dose
干预措施: HY209GEL Active
PART 2 Placebo
Placebo group
干预措施: Placebo
结局指标
主要结局
Percentage change in Eczema Area and Severity Index (EASI) score
时间窗: at Week 8
To achieve lower score means disease improvement .