A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 92
- 主要终点
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg 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
2 mg Baricitinib
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
4 milligram (mg) Baricitinib
4 mg 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
4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
干预措施: Placebo (Drug)
2 mg Baricitinib
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Placebo (Drug)
1 mg Baricitinib
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
1 mg Baricitinib
1 mg 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 administered orally once daily.
干预措施: Placebo (Drug)
4 mg Baricitinib Maximum Extended Enrollment Cohort
4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
4 mg Baricitinib Maximum Extended Enrollment Cohort
4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
干预措施: Placebo (Drug)
2 mg Baricitinib Maximum Extended Enrollment Cohort
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
2 mg Baricitinib Maximum Extended Enrollment Cohort
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
干预措施: Placebo (Drug)
1 mg Baricitinib Maximum Extended Enrollment Cohort
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
干预措施: Baricitinib (Drug)
1 mg Baricitinib Maximum Extended Enrollment Cohort
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
干预措施: Placebo (Drug)
Placebo Maximum Extended Enrollment Cohort
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, 2 mg, or 4 mg Baricitinib)
时间窗: 16 Weeks
The IGA measures the investigator's global assessment of the participant's 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 IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)(16 Weeks)
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)(16 Weeks)
- Percentage of Participants Achieving EASI90(16 Weeks)
- Percent Change From Baseline in EASI Score(Baseline, 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)
- Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)(Baseline, 16 Weeks)
- Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)(Baseline, 16 Weeks)
- Percentage of Participants Achieving EASI50(16 Weeks)
- Percentage of Participants Achieving IGA of 0(16 Weeks)
- Change From Baseline in SCORAD(Baseline, 16 Weeks)
- Percentage of Participants Achieving SCORAD90(16 Weeks)
- Change From Baseline in Body Surface Area (BSA) Affected(Baseline, 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 Total Score of the Patient Oriented Eczema Measure (POEM)(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 in the Dermatology Life Quality Index (DLQI)(Baseline, 16 Weeks)
- Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire(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)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)(Baseline, 16 Weeks)
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement(4 Weeks)