A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopicdermatitis

ovartis Pharma Services AG0 个研究点目标入组 92 人开始时间: 2013年5月21日最近更新: 2015年11月23日

适应症

试验速览

暂无简介。

•- Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months plus three, or more, of the following:
•History of involvement of the skin creases (fronts of
•elbows, behind knees, fronts of ankles, around neck or around eyes)
•Personal history of asthma or hay fever
•History of generally dry skin in the past year
•Onset before age of 2 years
•Visible flexural dermatitis
•- Patients with an EASI score of =15 at screening and stable AD (not currently
•experiencing an acute flare of their AD)
•- Patients that have been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion, or could not use topical drugs (due to
•contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment.
•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 92
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Pregnant or nursing (lactating) women
•- Women of child-bearing potential unless they are using a effective method of birth control (as further defined in study protocol)
•- Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents such as cyclosporine, mycophenolate, or oral tacrolimus, or therapeutic proteins.

发起方