NCT03334422已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Patients With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 80
- 主要终点
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
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 been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- •Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
- •Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- •Agree to use emollients daily.
排除标准
- •Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
- •A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
- •Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
- •Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
- •Have been treated with the following therapies:
- •Monoclonal antibody for less than 5 half-lives prior to randomization.
- •Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- •Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- •Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- •Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
- •Have had major surgery within the past eight weeks or are planning major surgery during the study.
- •Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- •Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
- •Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- •Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
- •Have specific laboratory abnormalities.
- •Have received certain treatments that are contraindicated.
- •Pregnant or breastfeeding.
研究组 & 干预措施
4 Milligram (mg) Baricitinib
Experimental
4mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match
干预措施: Baricitinib (Drug)
4 Milligram (mg) Baricitinib
Experimental
4mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match
干预措施: Placebo (Drug)
2mg Baricitinib
Experimental
2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
2mg Baricitinib
Experimental
2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Placebo (Drug)
1mg Baricitinib
Experimental
1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
1mg Baricitinib
Experimental
1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo administered orally once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)
时间窗: 16 Weeks
The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
次要结局
- Percentage of Participants Achieving EASI90(16 Weeks)
- Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)(16 Weeks)
- Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)(16 Weeks)
- Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1mg Baricitinib)(16 Weeks)
- Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)(Baseline, 16 Weeks)
- Change From Baseline in Skin Pain NRS(Baseline, 16 Weeks)
- Percentage of Participants Achieving EASI50(16 Weeks)
- Percentage of Participants Achieving IGA of 0(16 Weeks)
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)(16 Weeks)
- Percent Change From Baseline on EASI Score(Baseline, 16 Weeks)
- Change From Baseline in SCORAD(Baseline, 16 Weeks)
- Percentage of Participants Achieving SCORAD90(16 Weeks)
- Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment(16 Weeks)
- Percent Change From Baseline in Itch NRS(Baseline, 16 Weeks)
- Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score(Baseline, 16 Weeks)
- Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)(Baseline, 16 Weeks)
- Change From Baseline on the Dermatology Life Quality Index (DLQI)(Baseline, 16 Weeks)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)(Baseline, 16 Weeks)
- Change From Baseline in Body Surface Area (BSA) Affected(Baseline, 16 Weeks)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm(Baseline, 16 Weeks)
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement(4 Weeks)
- Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)(Baseline, 16 Weeks)
- Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire(Baseline, 16 Weeks)
研究者
研究点 (80)
Loading locations...
相似试验
已完成
3 期
A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03334396Eli Lilly and Company660
已完成
3 期
A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03435081Eli Lilly and Company440
已完成
2 期
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney DiseaseDiabetic Kidney DiseaseNCT01683409Eli Lilly and Company130
招募中
3 期
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia AreataAreata AlopeciaHypotrichosisHair DiseasesSkin DiseasesPathological Conditions, AnatomicalAlopeciaNCT05723198Eli Lilly and Company595
已完成
3 期
A Study in Participants With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01711359Eli Lilly and Company588