NCT03435081已完成3 期
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
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
- 440
- 试验地点
- 81
- 主要终点
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult 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 a diagnosis of atopic dermatitis (AD) at least 12 months before screening.
- •Have moderate to severe AD, including all of the following:
- •EASI score ≥16
- •IGA score of ≥3
- •≥10% of BSA involvement
- •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 before randomization
- •received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization
- •received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- •have had an intra-articular corticosteroid injection within 6 weeks of planned randomization
- •probenecid at the time of randomization that cannot be discontinued for the duration of the study
- •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: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- •Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE.
- •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 milligram (mg) Baricitinib
Experimental
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
干预措施: Placebo (Drug)
2 milligram (mg) Baricitinib
Experimental
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
干预措施: Baricitinib (Drug)
1 mg Baricitinib
Experimental
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
干预措施: Baricitinib (Drug)
1 mg Baricitinib
Experimental
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo administered orally every day.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
时间窗: Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
次要结局
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement(Week 4)
- Percentage of Participants Achieving EASI75 (1 mg Baricitinib)(Week 16)
- Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS)(16 Weeks)
- Percentage of Participants Achieving EASI90(Week 16)
- Percent Change From Baseline in EASI Score(Baseline, Week 16)
- Change From Baseline in Skin Pain NRS(Baseline, Week 16)
- Change From Baseline in Body Surface Area (BSA) Affected(Baseline, Week 16)
- Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment(Week 16)
- Percent Change From Baseline in Itch NRS(Baseline, Week 16)
- Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)(Baseline, Week 16)
- Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)(Week 16)
- Percentage of Participants Achieving IGA of 0(Week 16)
- Percentage of Participants Achieving SCORAD90(Week 16)
- Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)(Baseline, Week 16)
- Percentage of of Participants Achieving EASI50(Week 16)
- Change From Baseline in SCORAD(Baseline, Week 16)
- Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score(Baseline, Week 16)
- Change From Baseline on the Hospital Anxiety Depression Scale (HADS)(Baseline, Week 16)
- Change From Baseline on the Dermatology Life Quality Index (DLQI)(Baseline, Week 16)
- Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire(Baseline, Week 16)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm(Baseline, Week 16)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)(Baseline, Week 16)
研究者
研究点 (81)
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