A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Fold-Change in Epidermal Thickness of Lesional Skin
研究概览
简要总结
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families.
In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.
详细描述
This is a randomized, double-blind, pilot study of a total of 44 subjects with AD (22 with intrinsic and 22 with extrinsic AD) consisting of 2 phases. Subjects will be randomized (2:1) to either receive secukinumab 300 mg or placebo via subcutaneous injection using 2 prefilled syringes.
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)
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 subject at least 18 years of age
- •If female, the subject is not pregnant or nursing
- •Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- •Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- •Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
- •Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- •Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis.
- •Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
- •Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
排除标准
- •Male or female subject at least 18 years of age
- •If female, the subject is not pregnant or nursing
- •Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- •Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- •Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
- •Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- •Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis.
- •Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
- •Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
研究组 & 干预措施
Secukinumab
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
干预措施: Secukinumab (Drug)
Placebo
Placebo via subcutaneous injection using 2 prefilled syringes
干预措施: Placebo (Drug)
结局指标
主要结局
Fold-Change in Epidermal Thickness of Lesional Skin
时间窗: at Week 16
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
次要结局
- Fold-Change in K16 Expression of Lesional Skin(at Week 16)
- Percentage Change From Baseline in SCORAD Score(at Week 16)
- Fold-Change in Elafin/Pi3 Level From Baseline(at Week 16)
- Fold-Change in CCL20 Level(at Week 16)
- Fold-Change in A8 Level(at Week 16)
- Fold-Change in S100A7 Level(at Week 16)
- Fold-Change in CXCL1 Level(at Week 16)
- Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1(Week 16, Week 32, Week 52)
- Number of Patients With SCORAD-50(Week 4, Week 16, Week 32, Week 52)
- Fold-Change in A12 Level(at Week 16)
- Number of Patients Who Achieve EASI-50 Score(Week 4, Week 16, Week 32, Week 52)
- Percentage Change From Baseline in EASI Scores(at Week 16)
- Fold-Change in A9 Level(at Week 16)
研究者
Emma.Guttman
Associate Professor
Icahn School of Medicine at Mount Sinai