EUCTR2014-003384-38-DE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
- 475
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 428
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
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
- •5. Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception, whenever engaging in heterosexual intercourse, throughout the duration of the study and for 120 days after last dose of study drug. These include hormonal contraceptives, intrauterine device, or double barrier contraception (eg, condom + diaphragm), or a male partner with documented vasectomy. Additional requirements for acceptable contraception may apply in certain countries, based on local regulations. Investigators in these countries will be notified accordingly in a protocol clarification letter.
- •*For females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of =25 mU/mL must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception.
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