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

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 475 人开始时间: 2015年2月25日最近更新: 2016年10月24日

适应症

试验速览

暂无简介。

•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

•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
•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

发起方