A Multicenter, Open-Label, 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
- 终止
- 入组人数
- 374
- 试验地点
- 74
- 主要终点
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
研究概览
简要总结
This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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%- 50% 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)
- •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 episodes 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, 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
Placebo/Baricitinib 2-milligram (mg)
Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
干预措施: Baricitinib (Drug)
Baricitinib 1-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
干预措施: Baricitinib (Drug)
Baricitinib 2-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
干预措施: Baricitinib (Drug)
Baricitinib 2-mg Open-Label Addendum
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
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. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
次要结局
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1(Week 16)
- Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%(Week 16)
- Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)(Week 16)