A Randomized, Double-Blind, Vehicle-Controlled, Phase 2 Trial to Evaluate the Anti-pruritic Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 27
- 主要终点
- Daily Peak Pruritus Numerical Rating Scale (NRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are:
- What is the efficacy and safety of ASN008?
- What is the impact of ASN008 on itch in patients with atopic dermatitis? Participants will be asked to apply topical ASN008, or matching vehicle (placebo containing no active drug), to their eczema lesions twice daily for 4 weeks.
Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.
详细描述
All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial.
Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28.
Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET).
The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period.
A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.
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)
盲法说明
At all times, treatment and randomization information will be kept confidential and will not be released to the Sponsor's trial team until database lock is completed. Investigators, participants, and clinical staff will remain blinded throughout the trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants, 18 years or older, at the time of informed consent.
- •Diagnosis of mild to moderate AD for at least 12 months with no significant disease flares for at least 4 weeks before Screening (based upon medical chart, treating physician, or participant report with documented clinical confirmation by the Investigator)
- •Validated Investigator Global Assessment (vIGA) score of 2 or 3 at Day
- •Body surface area (BSA) affected by AD ≤20% at Day
- •Peak Pruritus NRS ≥7 at Day
- •Body mass index (BMI) ≤40 kg/m2 at Screening.
- •Willingness to avoid pregnancy or fathering children.
- •Participant is willing to participate for the duration of the trial, comply with all trial procedures, and is capable of giving informed consent.
排除标准
- •Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- •Active infection requiring treatment, including skin infections (including clinically infected AD).
- •History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments.
- •Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results.
- •Use of any of the following treatments within the indicated washout period before Day 1:
- •Doxepin, hydroxyzine, or diphenhydramine use within 1 week prior to Day
- •Use of topical product containing urea or any antihistamine within 1 week prior to Day
- •Use of systemic antibiotic within 2 weeks, or topical antibiotics within 1 week, prior to Day
- •Atopic dermatitis topical medication use within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, JAK inhibitors, tars, bleach, antimicrobials, medical devices, and bleach or oatmeal baths.
- •Psoralen-UV-A or UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day
- •Systemic medication use including biologics that could affect AD less than 6 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids), biologics and JAK inhibitors.
- •Known hypersensitivity to ASN008 or its excipients.
研究组 & 干预措施
ASN008 1.25%
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
干预措施: ASN008 (Drug)
ASN008 2.5%
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
干预措施: ASN008 (Drug)
ASN008 5%
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
干预措施: ASN008 (Drug)
ASN008 Matching Vehicle
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
干预措施: ASN008 Matching Vehicle (Other)
结局指标
主要结局
Daily Peak Pruritus Numerical Rating Scale (NRS)
时间窗: Baseline to Week 4
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
次要结局
- Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS(Baseline to Week 4)
- Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline to Week 4)
- Mean Change From Baseline in Total Body Surface Area (BSA)(Baseline to Week 4)
- Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)(Baseline to Week 4)