NL-OMON40359已完成2 期
A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopic dermatitis (CQAW039X2201) - CQAW039X2201
ovartis Pharma BV0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female adults aged 18-65 years.
- •* Atopic dermatitis (AD) (see protocol page 34 for details).
- •* Stable AD, EASI score *15 at screening.
- •* Has 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.
排除标准
- •* History of serious allergic reactions to any allergen (see protocol page 35 for details).
- •* Clinically significant ECG abnormalities (see protocol page 35 for details).
- •* History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (>450 ms for males and females).
- •* Use of topical prescription treatment within 2 weeks prior to initial dosing of study drug. Exception: see protocol page 35 for details.
- •* Recent previous systemic treatment. See protocol page 35 for types of treatment en wash-out.
- •* Patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within 1 month prior to granting informed consent.
- •* High dose statin therapy (see protocol page 36 for details).
- •* Excessive exposure to UV light in the 3 weeks prior to screening (see protocol page 36 for details).
- •* BMI < 17 or > 40 kg/m2.
- •* Pregnancy and breast feeding. Inadequate contraception, if relevant.
- •* Serious co-morbidities (see protocol page 37 for details).
研究者
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