Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home

NCT02417961 | Completed Phase 3 Results DMC

• 1 other identifier: D3250C00029
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 23

Brief Summary

The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.

Conditions

Asthma

Keywords

Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases,; Benralizumab

Outcome Measures

Primary Outcomes (3)

• Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home

  Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.

  Week 12, Week 16, and Weeks 12 and 16

• Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional

  Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.

  Week 12, Week 16

• Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)

  Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.

  Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16

Secondary Outcomes (4)

• The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score

  Week 0 (baseline) and weeks 4, 8, 12, 16, 20

• The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab

  Baseline, Week 8, Week 20, and Week 28

• The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels

  Baseline, Week 20, and Week 28

• The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)

  Baseline until Week 28

Study Arms (1)

Benralizumab 30 mg

EXPERIMENTAL

Benralizumab administered subcutaneously every 4 weeks

Biological: Benralizumab

Interventions

Benralizumab BIOLOGICAL

Benralizumab administered subcutaneously every 4 weeks

Benralizumab 30 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male and female patients aged 18 to 75 years of age at the time of Visit 1
• Patient or caregiver must be willing and able to self-administer the IP (Investigational product). Caregiver must be age of consent or older at the time of Visit 1, if applicable
• Weight of ≥40 kg
• Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 2 OR documented in the previous 12 months OR; Airflow variability in FEV1 ≥20% between pulmonary function testing documented in the 12 months prior to V2 OR; Airflow variability shown by \>20% diurnal variability in peak flow observed in the patient's asthma action plan
• Documented history of current treatment with ICS (Inhaled corticosteroids) and LABA (Long-acting β2 agonists). 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, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., LTRAs (Leukotriene receptor antagonists), tiotropium, theophylline, oral corticosteroids) are allowed
• Morning pre-bronchodilator (pre-BD) FEV1 of \>50% predicted at Visit 1 or Visit 2
• Not well controlled asthma as documented by either: An ACQ6 (Asthma Control Questionnaire 6) ≥1.5 OR; A peak flow of 60-80% predicted OR; An exacerbation, one or more, that required oral or systemic corticosteroids in the previous year OR; Any one of the following assessed by patient recall over the previous 2-4 weeks: Asthma symptoms \>2 days/week; OR / Nighttime awakenings 1 or more/week; OR / Short acting beta2-agonist use for symptom control (not for prevention of exercise induced asthma) \>2 days/week

You may not qualify if:

• Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), 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 (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
• 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
• Known history of allergy or reaction to the IP formulation
• History of anaphylaxis to any biologic therapy
• History of Guillain-Barré syndrome
• 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
• 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 period
• Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (23)

Research Site

Fountain Valley, California, United States

Location

Research Site

Walnut Creek, California, United States

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Research Site

Celebration, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Albany, Georgia, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Bellevue, Nebraska, United States

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Oklahoma City, Oklahoma, United States

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San Antonio, Texas, United States

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Ajax, Ontario, Canada

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Burlington, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Research Site

Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Research Site

Saint-Charles-Borromée, Quebec, Canada

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Research Site

Trois-Rivières, Quebec, Canada

Location

Related Publications (1)

• Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, Goldman M. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018 Apr 5;11:63-72. doi: 10.2147/JAA.S157762. eCollection 2018.

  PMID: 29670379 BACKGROUND

Related Links

• Related Info
• Redacted CSP

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Mitchell Goldman, Global Clinical Lead Benralizumab
• Organization: AstraZeneca

Mitchell.Goldman@astrazeneca.com

+1 301 398 0323

Study Officials

• Gary T. Ferguson, MD, PC

  Pulmonary Research Institute of Southeast Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 16, 2015
• Study Start: April 27, 2015
• Primary Completion: March 14, 2016
• Study Completion: March 14, 2016
• Last Updated: May 23, 2018
• Results First Posted: June 12, 2017

Record last verified: 2018-04

Locations

US (12); CA (11)