NCT04086121终止2 期
An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously 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
- 终止
- 入组人数
- 14
- 试验地点
- 10
- 主要终点
- Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
研究概览
简要总结
To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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
- •Patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; In the 1368-0032 re-allocation period (V7 to V11):
- •If an original non-responder from week 16 (V7), attained at least EASI 50 by last infusion (week 28) or by the EOS.
- •If an original responder from week 16 (V7) completed the last visit Week 28 (EOS) or dropped to a EASI 50 score prior to Week
- •Women of childbearing potential (WOCBP)1 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 for the duration of the trial and 16 weeks after last study drug administration. A list of contraception methods meeting these criteria is provided in the patient information.
排除标准
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, 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.
- •Active systemic infections during the last two weeks prior to first drug administration.
- •Currently enrolled in another investigational device or drug trial, except for 1368-
- •Any condition which would prevent the patient continuing on treatment in this trial 1368-0037
- •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.
- •History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
研究组 & 干预措施
Spesolimab 600 mg
Experimental
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
干预措施: Spesolimab (Drug)
结局指标
主要结局
Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
时间窗: From first dose until Week 48, up to 48 weeks.
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.
次要结局
- Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48(At baseline and at Week 48.)
- Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48(At baseline and at Week 48.)
- Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48(At baseline and at Week 48.)
- Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48(At baseline and at Week 48.)
- Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48(At baseline and at Week 48.)
研究者
研究点 (10)
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