A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 10
- 主要终点
- Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
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
- Double (Participant, Investigator)
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
- •Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:
- •EASI of 12 or more
- •Greater than or equal to 10% of body surface area involvement
- •Diagnosed with AD at least 2 years prior
- •Have a history of inadequate clinical response to other eczema treatments
排除标准
- •Females who are pregnant or nursing
- •Participants who do not agree to use adequate contraception
- •Are currently experiencing or have a history of:
- •Skin conditions such as psoriasis or lupus erythematosus
- •Skin disease that requires frequent hospitalizations or intravenous treatment
- •Compromised immunity
- •Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
- •Currently experiencing or have a history of:
- •Active or latent Tuberculosis or specific immunity disorders and infections
- •Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
- •Human Immunodeficiency Virus (HIV)
- •Hepatitis B, Hepatitis C, or chronic liver disease
- •Have received certain types of vaccinations
研究组 & 干预措施
Baricitinib
Administered once daily in multiple oral dose cohorts for 16 weeks
(Triamcinolone 0.1% topical also permitted)
干预措施: Baricitinib (Drug)
Baricitinib
Administered once daily in multiple oral dose cohorts for 16 weeks
(Triamcinolone 0.1% topical also permitted)
干预措施: Triamcinolone (Optional) (Drug)
Placebo
Administered orally once daily, for 16 weeks
(Triamcinolone 0.1% topical also permitted)
干预措施: Placebo (Drug)
Placebo
Administered orally once daily, for 16 weeks
(Triamcinolone 0.1% topical also permitted)
干预措施: Triamcinolone (Optional) (Drug)
结局指标
主要结局
Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
时间窗: Week 16
The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
次要结局
- Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16(Baseline, Week 16)
- Change From Baseline in the EASI at Week 16(Baseline, Week 16)
- Percentage Change From Baseline in the EASI at Week 16(Baseline, Week 16)
- Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16(Baseline, Week 16)
- Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16(Baseline, Week 16)
- Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16(Baseline, Week 16)
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib(Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.)