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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT01202903
Eligibility Criteria:
Inclusion Criteria:
* Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight \> 20 kg and ≤ 150 kg)
* Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
* Received medium-to-high dose inhaled corticosteroid \> 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
* Met specific asthma exacerbations eligibility criteria prior to the screening period
* Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
* Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
* FEV1 ≥ 40% and \< 80% of the predicted normal value for the patient (using local standards), after withholding bronchodilators at Visit 2
Exclusion Criteria:
* Used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. For biological agent-based investigational drugs, such as monoclonal antibodies, at least six months will need to have passed between the last administration of the drug and the patient's Screening Visit.
* History of malignancy
* History of allergies and diseases that could interfere with the analyses
* Clinically significant abnormality on a 12-lead ECG recorded at Visit 1
* Elevated IgE levels for reasons other than allergy
* Current smokers, or a former smoker with a smoking history of \> 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
* Receiving specific medications
* Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01202903
Study Brief:
Protocol Section:
NCT01202903