Status:
WITHDRAWN
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Peanut Allergy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01451450
Last Update
July 23 2012
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