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)

Phase 2

Withdrawn

Conditions: peanut allergy
10001708

Registration Number: NL-OMON37823

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>QGE031 dose response relationship for the increase in the threshold dose of<br /><br>peanut protein that induces objective hypersensitivity reactions after<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The percentage of patients that experienced an increase from baseline to the<br /><br>end of treatment period in the threshold dose of at least 2 steps (or 10 fold)<br /><br>increase in peanut dose; safety and tolerability.</p><br>