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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT01596712
Eligibility Criteria:
Inclusion Criteria:
* Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
* Serum IgE level must be equal to or greater than 30 IU/mL at screening.
Exclusion Criteria:
* Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
* Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
* Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
* Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
* Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
* Prior use of Xolair® or other anti-IgE antibodies
* Concomitant use of allergy vaccination therapy
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01596712
Study Brief:
Protocol Section:
NCT01596712