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Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma (PONENTE)

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ClinicalTrials.gov Identifier: NCT03557307
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

Condition or disease Intervention/treatment Phase
Asthma Biological: Benralizumab Phase 3

Detailed Description:
This is an open-label, multicenter study designed to evaluate efficacy and safety of reducing daily oral corticosteroid (OCS) use after initiation of 30 mg dose of benralizumab administered subcutaneously (SC) in patients with severe eosinophilic asthma receiving high-dose inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) and OCS with or without additional asthma controller(s).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Benralizumab
Benralizumab subcutaneous injection
Biological: Benralizumab
Benralizumab subcutaneous injection




Primary Outcome Measures :
  1. Patients who achieve 100% reduction in daily OCS dose [ Time Frame: Visit 3 to End of OCS Reduction Phase (up to 38 weeks) ]
    Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma

  2. Patients who achieve 100% reduction or a daily OCS dose of ≤5mg [ Time Frame: Visit 3 to End of OCS Reduction Phase (up to 38 weeks) ]
    Patients who achieve 100% reduction or a daily OCS dose of ≤5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma


Secondary Outcome Measures :
  1. Patients who achieve a daily OCS of ≤5mg [ Time Frame: Visit 3 to End of OCS Reduction Phase (up to 38 weeks) ]
    Patients who achieve a daily OCS dose of ≤5 mg that are sustained over at least 4 weeks without worsening of asthma

  2. Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in daily OCS dose [ Time Frame: Visit 3 to End of OCS Reduction Phase (up to 38 weeks) ]
    Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in average daily OCS dose, sustained over at least 4 weeks without worsening of asthma

  3. Change from baseline in average daily OCS dose (mg) [ Time Frame: Visit 3 to End of OCS Reduction Phase (up to 38 weeks) ]
    Change from baseline in average daily OCS dose (mg) from start of OCS reduction to end of the OCS reduction phase



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Peripheral blood eosinophil count of ≥150 cells/μL assessed by central lab at Visit 1 or ≥ 300 cells/μL in the past 12 months
  2. History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS is the highest approved dose in a country) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers
  3. Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.
  4. Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.
  5. Non-smokers, current smokers or former smokers with a smoking history of <20 pack-years at Visit 1

Exclusion Criteria:

  1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts
  2. Known history of allergy or reaction to the study drug formulation
  3. History of anaphylaxis to any biologic therapy
  4. 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
  5. Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)
  6. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
  7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN) confirmed at Visit 1.
  8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
  9. Coincident primary adrenal failure (Addison's disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)
  10. Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica
  11. Exclusion from genetic research may be for any of the exclusion criteria specified in the main study or allogeneic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557307


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03557307     History of Changes
Other Study ID Numbers: D3250C00065
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AstraZeneca:
Asthma
Severe Asthma
Oral Corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases