NCT03822832已完成2 期
Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 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
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 23
- 主要终点
- Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16
研究概览
简要总结
The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
- •Male or female patients, 18 to 75 years of age at screening
- •Diagnosis of atopic dermatitis for at least 1 year
- •Moderate to severe atopic dermatitis defined as:
- •At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at screening and baseline
- •Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16 at baseline
- •Investigator Global Assessment (IGA) of at least 3 at screening and baseline
- •Documented history of inadequate response to topical corticosteroid as judged by the investigator
- •Willing to use a standard emollient for the duration of the study
- •Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
排除标准
- •Use of topical corticosteroids or other agents for atopic dermatitis within 7 days prior to first dose of trial treatment.
- •Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration
- •Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
- •Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
- •History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
- •Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to first drug administration, per investigator assessment.
- •Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- •Active or Latent Tuberculosis (TB):
- •Patients with active tuberculosis are excluded.
- •Patients with a positive QuantiFERON TB test during screening are excluded, unless:
- •Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practice/guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)
- •Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once
- •If the QuantiFERON TB test result is not available or provides indeterminate results after repeat testing: A tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent) is considered positive.
- •Currently enrolled in another investigational device or drug trial, or less than 30 days or 5 half lives, whichever is longer since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
- •Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.
- •Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug adminstration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
- •Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
研究组 & 干预措施
Spesolimab
Experimental
i.v.
干预措施: BI 655130 (Drug)
Placebo
Placebo Comparator
i.v.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16
时间窗: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.
次要结局
- Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4(Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.)
- Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16(Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.)
- Number of Patients With Drug Related Adverse Events (AEs)(Up to 28 weeks, see endpoint description for more details.)
- Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4(Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.)
- Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16(Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.)
- Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16(Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.)
- Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4(Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.)
- Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16(Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.)
研究者
研究点 (23)
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