A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18-50 years with peanut allergy (CQGE031A2208) - CQGE031A2208

ovartis0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Male and female subject 18-50y of age , who have a diagnosis of acute peanut allergy as manifested by urticaria, angioedema, respiratory tract symptoms, or hypotensive symptoms, with acute onset of symptoms after ingestion (up to 2h)
•Positive food challenge test at baseline
•Weight at least 40 kg.

•Prior exposure to any monoclonal antibody treatment, e.g. prior QGE031 or Xolair use within 6 months prior to study entry
•Poorly controlled asthma
•Concomitant use of systemic immunosuppressant, beta blockers, ACE inhibitors or tricyclic antidepressants
•History of any of severe anaphylaxis as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
•Women of child-bearing potential, unless using highly effective contraceptive measures.

发起方