EUCTR2014-003384-38-ES进行中（未招募）1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE EFFICACY AND SAFETY OF MULTIPLE DUPILUMAB DOSE REGIMENS ADMINISTERED AS MONOTHERAPY FOR MAINTAINING TREATMENT RESPONSE IN PATIENTS WITH ATOPIC DERMATITIS. - Liberty AD Solo - Continue
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A patient must meet the following criteria to be eligible for inclusion in the study:
- •1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416).
- •2. Must have achieved at least 1 of the following 2 treatment success criteria:
- •IGA = 0 or 1 (clear or almost clear) at week 16 OR EASI-75 (at least 75% reduction in EASI score from baseline to week 16)
- •3. Must be willing and able to comply with clinic visits and study-related procedures
- •4. Must provide signed informed consent
- •5. Must be able to understand and complete study-related questionnaires
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •1. Receipt of rescue medication for AD in the initial treatment study
- •2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study
- •3. Planned or anticipated major surgical procedure during the patient?s participation in this study
- •4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study
- •Birth control exclusion criterion # 5is listed in protocol section 4.2.2
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