Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
- Registration Number
- NCT01451450
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).
- Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.
Main
Exclusion Criteria
- Prior exposure to any monoclonal antibody treatment
- Asthma patients on maintenance long acting beta-agonists
- Use of systemic corticosteroids
- Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists
- Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QGE031 A QGE031 - QGE031 B QGE031 - QGE031 C QGE031 - QGE031 D QGE031 - Placebo A Placebo - Placebo B Placebo - Placebo C Placebo - Placebo D Placebo -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method