Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home

NCT02918071 | Completed Phase 3 Results

• 1 other identifier: D3250C00031
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 25

Brief Summary

The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) 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 of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home

  Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.

  Week 12, Week 16, Week 12 and 16

• Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional

  AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.

  Week 12, Week 16

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

  Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.

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

Secondary Outcomes (4)

• 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)

Arm Benralizumab

EXPERIMENTAL

Benralizumab administered subcutaneously every 4 weeks

Biological: Benralizumab

Interventions

Benralizumab BIOLOGICAL

Benralizumab administered subcutaneously every 4 weeks

Arm Benralizumab

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 Investigational product (IP). 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 airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 1A or Visit 2
• Documented history of current treatment with Inhaled corticosteroids (ICS) and Long-acting β2 agonists (LABA). 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., Leukotriene receptor antagonists (LTRAs), tiotropium, theophylline, oral corticosteroids) are allowed
• Pre-bronchodilator (pre-BD) FEV1 of \>50% predicted normal at Visit 1 or 1A or Visit 2
• Not well controlled asthma as documented by either: An Asthma Control Questionnaire 6 (ACQ6 ) ≥1.5 OR; A peak flow of 60-80% predicted OR; One or more exacerbation that required oral or systemic corticosteroids in the previous year

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
• 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 (25)

Research Site

Northridge, California, 91324, United States

Location

Research Site

Riverside, California, 92506, United States

Location

Research Site

Westminster, California, 92683, United States

Location

Research Site

Miami, Florida, 33126, United States

Location

Research Site

Winter Park, Florida, 32789-4681, United States

Location

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Albany, Georgia, 31707, United States

Location

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Minneapolis, Minnesota, 55402, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Canton, Ohio, 44718, United States

Location

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Edmond, Oklahoma, 73034, United States

Location

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Boerne, Texas, 78006, United States

Location

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McKinney, Texas, 75071, United States

Location

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Plano, Texas, 75093, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

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Sherwood Park, Alberta, T8L 0N2, Canada

Location

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Ajax, Ontario, L1S 2J5, Canada

Location

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Burlington, Ontario, L7N 3V2, Canada

Location

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Kanata, Ontario, K2L 3C8, Canada

Location

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Mississauga, Ontario, L5A 3V4, Canada

Location

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Montreal, Quebec, H3G 1L5, Canada

Location

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Montreal, Quebec, H4J 1C5, Canada

Location

Research Site

Québec, Quebec, G1G 3Y8, Canada

Location

Research Site

Québec, Quebec, G1V 4W2, Canada

Location

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Sherbrooke, Quebec, J1H 5N4, Canada

Location

Research Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Related Links

• Related Info
• Related Info

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: Ubaldo Martin, Global Clinical Lead Benralizumab
• Organization: AstraZeneca

Ubaldo.Martin@astrazeneca.com

+1 301 398 0163

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: September 27, 2016
• First Posted: September 28, 2016
• Study Start: November 10, 2016
• Primary Completion: August 21, 2017
• Study Completion: August 21, 2017
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-10

Locations

US (14); CA (11)