Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01914757
First received: July 31, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.


Condition Intervention Phase
Asthma
Biological: Benralizumab
Biological: Placebo
Biological: Benralizumab (adolescent patients in the EU)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the effect of benralizumab on asthma exacerbations in adult and adolescent patients with uncontrolled asthma. [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: No ]
    Annual asthma exacerbation rate


Secondary Outcome Measures:
  • To assess the effect of benralizumab on pulmonary function [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: No ]
    Endpoints: Pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1 at the study centre

  • To assess the effect of benralizumab on asthma symptoms and other asthma control metrics (as per the ePRO) [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: No ]
    Endpoints: - Asthma symptom score (total,daytime and night time) - Rescue medication use - Home lung function (morning and evening PEF) - Nights with awakening due to asthma - ACQ-6

  • To assess the effect of benralizumab on emergency room visits and hospitalizations due to asthma [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: No ]
    Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization

  • To evaluate the pharmacokinetics and immunogenicity of benralizumab [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: No ]
    Endpoints: - PK parameters- Anti-drug antibodies (ADA)

  • To assess the safety and tolerability of benralizumab [ Time Frame: Immediately following the first administration of study drug through Study Week 56. ] [ Designated as safety issue: Yes ]
    Endpoints: - AE/SAE - Laboratory variables - ECG - Physical Examination


Estimated Enrollment: 2014
Study Start Date: August 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benralizumab Arm A
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Other Name: Benralizumab
Experimental: Benralizumab Arm B
Benralizumab administered subcutaneously.
Biological: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Other Name: Benralizumab
Placebo Comparator: Placebo
Placebo administered subcutaneously.
Biological: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.
Other Name: Placebo
Experimental: Benralizumab Arm C
Benralizumab administered subcutaneously
Biological: Benralizumab (adolescent patients in the EU)
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Other Name: Benralizumab

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
  4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.- For fixed ICS-LABA combination products, the ICS criterion will be considered met by the highest locally approved maintenance dose for ages 18 and older

Exclusion criteria:

  1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, 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
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
  4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914757

Contacts
Contact: Clinical Trial Transparency ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Clinical Study Information +1 800-236-9933 information.center@astrazeneca.com

  Show 238 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Fitzgerald, MD, PhD, Professor of Medicine The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01914757     History of Changes
Other Study ID Numbers: D3250C00018
Study First Received: July 31, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Japan: Ministry of Health, Labor and Welfare
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Ukraine: Ministry of Health
Sweden: Medical Products Agency
Germany: Paul-Ehrlich-Institut
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Philippines: Bureau of Food and Drugs

Keywords provided by AstraZeneca:
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

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

ClinicalTrials.gov processed this record on July 31, 2014