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 years and older with peanut allergy

ovartis Pharma AG0 个研究点目标入组 110 人开始时间: 2011年8月8日最近更新: 2012年8月28日

试验速览

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•Written informed consent obtained before any assessment is performed
•Must 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 2 hours).
•Have a positive peanut food challenge at baseline , i.e. have objective allergic events at a level of 300mg or below of peanut protein but not to the placebo.
•Eligibility to the food challenge requires fulfillment of all other eligibility criteria at visit 1.
•Must weigh = 40kg
•Additional inclusion criteria are listed in the clinical study protocol.
•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 110
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Prior exposure to any monoclonal antibody treatment, e.g. prior QGE031 or Xolair® use within 6 months prior to study entry
•Poorly controlled asthma. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ). Patients with a score =0.75 won’t be eligible for this study. Also, patients should have a FEV1 >70% of their predicted value.
•Concomitant use of systemic immunosuppressant, beta blockers, ACE inhibitors or tricyclic antidepressants
•History of severe anaphylaxis to peanut or omalizumab 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 they use highly effective contraception
•Additional exclusion criteria are listed in the clinical study protocol.

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