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

NCT ID: NCT02417961

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-27
• Study Completion Date: 2016-03-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Benralizumab 30 mg

Benralizumab administered subcutaneously every 4 weeks

Group Type: EXPERIMENTAL

Benralizumab

Intervention Type: BIOLOGICAL

Benralizumab administered subcutaneously every 4 weeks

Interventions

Benralizumab

Benralizumab administered subcutaneously every 4 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary T. Ferguson, MD, PC

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Research Institute of Southeast Michigan

Locations

Research Site

Fountain Valley, California, United States

Research Site

Walnut Creek, California, United States

Research Site

Celebration, Florida, United States

Research Site

Ocala, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Winter Park, Florida, United States

Research Site

Albany, Georgia, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

St Louis, Missouri, United States

Research Site

Bellevue, Nebraska, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

San Antonio, Texas, United States

Research Site

Calgary, Alberta, Canada

Research Site

Vancouver, British Columbia, Canada

Research Site

Ajax, Ontario, Canada

Research Site

Burlington, Ontario, Canada

Research Site

Mississauga, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Pointe-Claire, Quebec, Canada

Research Site

Québec, Quebec, Canada

Research Site

Saint-Charles-Borromée, Quebec, Canada

Research Site

Trois-Rivières, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 29670379 (View on PubMed)

Related Links

http://doi.org/10.2147/JAA.S157762

Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3529&filename=D3250C00029_Clinical%20Study%20Protocol_GREGALE%20-%20Redacted.pdf

Redacted CSP

Other Identifiers

D3250C00029

Identifier Type: -

Identifier Source: org_study_id