Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT01451450
Eligibility Criteria:
Main 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01451450
Study Brief:
Protocol Section:
NCT01451450