A randomized, double-blind, multi-center, parallel-group, placebo-controlled dose-ranging study to assess the efficacy and safety of nemolizumab (CD14152) in moderate-to-severe atopic dermatitis subjects with severe pruritus receiving topical corticosteroids - Dose-ranging study of nemolizumab in atopic dermatitis

GALDERMA R&D, SNC0 个研究点目标入组 351 人开始时间: 2017年9月22日最近更新: 2018年12月10日

研究概览

暂无简介。

•- Male or female subjects = 18 years (or legal age when higher)
•- Chronic AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 2 years before the visit
•- Eczema Area and Severity Index (EASI) score = 12
•- IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)
•- AD involvement = 10% of BSA
•- Severe pruritus, defined as average of pruritus Numeric Rating Score (NRS) for the maximum intensity = 7 during the 7 days prior to the visit.
•NOTE: A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
•- Documented recent history (within 6 months before the visit) of inadequate response to topical medications
•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 166
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•- Body weight < 45 kg
•- Subjects with a medical history of asthma that fulfil any one or more of the scenarios below:
•* Had an asthma exacerbation requiring hospitalization in the last 12 months before screening visit
•* Whose asthma has not been well-controlled (i.e. symptoms >2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the last 3 months before the screening visit
•* Peak Expiratory Flow (PEF) <80% of the predicted value
•- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period.
•- Pregnant women (with a positive serum pregnancy test result at the screening visit), breastfeeding women, or women planning to become
•pregnant during the clinical trial
•- History of intolerance to low or mid potency TCS or for whom TCS is not advisable (e.g. hypersensitivity to TCS or to any other ingredient
•contained in the TCSs to be used in the study, significant skin atrophy)

发起方

GALDERMA R&D, SNC