EUCTR2017-001040-35-ATActive, not recruitingPhase 1
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment (ANDHI) - ANDHI
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 630
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
- •2.Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS plus asthma controller, for at least 12 months prior to Visit 1. Other acceptable asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene inhibitor, theophylline preparations or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent).
- •3.Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1; see inclusion criterion 2 for acceptable other asthma controllers.
- •- For ICS/LABA combination preparations, highest-strength maintenance doses approved in the given country will meet this criterion.
- •- If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose.
- •4.History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose.
- •5.ACQ6 score =1.5 at Visit 1.
- •6.Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2
- •Note: Spirometry testing should only be performed if the patient meets the asthma medication hold for lung function testing, the test should be postponed to another day prior to Visit 3 to improve the chances of achieving a qualifying FEV1 that is not affected by bronchodilator medication.
- •7. Evidence of asthma as documented by excessive variability in lung function by satisfying =1 of the criteria below: a) Airway reversibility (FEV1 =12%) using a short-acting bronchodilator demonstrated at Visit 2 or Visit 3. b) Airway reversibility to short-acting bronchodilator (FEV1 =12%) documented* during the 12 months prior to enrolment Visit 1. c) Daily diurnal peak flow variability of >10% when averaged over 7 continuous days during the study run-in period. d) An increase in FEV1 of =12% and 200 mL after a therapeutic trial of systemic corticosteroid (eg, OCS), given outside of an asthma exacerbation, documented in the 12 months prior enrolment Visit 1. e) Airway hyper-responsiveness documented in the 24 months prior to randomization Visit 4.
- •8. Peripheral blood eosinophil count either: =300 cells/µL assessed by central laboratory at either Visit 1 or Visit 2 OR =150 to <300 cells/µL assessed by central laboratory at either Visit 1 or Visit 2, IF =1 of the following 5 clinical criteria (a to e) is met: a) Using maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent) at screening. b) History of nasal polyposis. c) Age of asthma onset =18 years. d) Three or more documented exacerbations requiring systemic corticosteroid treatment during the 12 months prior to screening. e) Pre-bronchodilator forc
Exclusion Criteria
- •1.Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease [COPD], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
- •2.Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
- •3.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •Affect the safety of the patient throughout the study.
- •Influence the findings of the studies or their interpretations.
- •Impede the patient’s ability to complete the entire duration of study.
- •4.Known history of allergy or reaction to any component of the IP formulation.
- •5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
- •6.Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the Investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete entire duration of the study.
- •7.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments.
- •8.History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
- •9.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
- •10.Current smokers or former smokers with a smoking history of =10 pack years. A former smoker is defined as a patient who quit smoking 6 months prior to Visit 1.
- •11.Current malignancy, or history of malignancy, except for:
- •Patients who have had non-melanoma skin cancers or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent is obtained.
- •Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent is obtained.
- •12.Approved or off-label use of systemic immunosuppressive medications within 3 months prior to the date informed consent is obtained. These include but are not limited to small molecules such as methotrexate, cyclosporine, azathioprine, and immunosuppressive/immunomodulating biologics such as tumor necrosis factor (TNF) blockers. Regular use of systemic (oral) corticosteroids is also excluded except for the indication of asthma.
- •13.Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of Visit 1). Acceptable washout periods for other asthma biologics: Other eosinophil lowering products indicated
Investigators
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