Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma

NCT02322775 | Completed Phase 3 Results

• 2 other identifiers: D3250C000322014-004427-40
• Study Type: interventional
• Target: 211
• Locations: 6 countries
• Sites: 57

Brief Summary

The purpose of this trial is to confirm the safety and clinical benefit of benralizumab administration in asthma patients with mild to moderate persistent asthma in order to gain an understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12

  The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12.

  Baseline, Week 4, Week 8 and Week 12

Secondary Outcomes (10)

• Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

• Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

• Change From Baseline in Total Asthma Symptom Score at Week 12

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

• Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

• Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Study Arms (2)

Arm A

EXPERIMENTAL

Benralizumab administered subcutaneously every 4 weeks

Biological: Benralizumab

Arm B

EXPERIMENTAL

Placebo administered subcutaneously every 4 weeks

Biological: Placebo

Interventions

Benralizumab BIOLOGICAL

Benralizumab administered subcutaneously every 4 weeks

Arm A

Placebo BIOLOGICAL

Placebo administered subcutaneously every 4 weeks

Arm B

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.
• Female and male aged 18 to 75 years, inclusively, at the time of Visit 1.
• Weight of ≥40 kg.
• Evidence of asthma as documented by post-bronchodilator (post-BD) reversibility in FEV1 of ≥ 12% demonstrated at Visit 2.
• Documented use of 1 of the following types of asthma therapy at time of informed consent: Low- to medium-dose ICS (ie, 100 to 500 μg fluticasone dry powder formulation equivalents total daily dose) with or without other controller medications, eg, an LTRA and/or theophylline or Low-dose ICS/LABA fixed combination therapy (eg, the lowest regular maintenance dose approved in the local country will meet this criterion)
• Morning pre-bronchodilator (pre-BD) FEV1 of \> 50% to ≤ 90% predicted at Visit 2.

You may not qualify if:

• Clinically important pulmonary disease other than asthma (eg, 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 (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
• nfluence 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 investigational product 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/run-in 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.
• Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
• A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
• History of cancer:
• Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
• Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (57)

Research Site

Los Angeles, California, 90048, United States

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Rolling Hills Estates, California, 90274, United States

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Clearwater, Florida, 33756, United States

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Orlando, Florida, 32825, United States

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Blue Island, Illinois, 60406, United States

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Skillman, New Jersey, 08558, United States

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Charlotte, North Carolina, 28207, United States

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Monroe, North Carolina, 28112, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45231, United States

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Grove City, Ohio, 43123, United States

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Oklahoma City, Oklahoma, 73103, United States

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Medford, Oregon, 97504, United States

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Spartanburg, South Carolina, 29303, United States

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El Paso, Texas, 79903, United States

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San Antonio, Texas, 78229, United States

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Vancouver, British Columbia, V5Z 1M9, Canada

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Ajax, Ontario, L1Z 0M1, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Hamilton, Ontario, L9C 2Y6, Canada

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Ottawa, Ontario, K2H 8T5, Canada

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Toronto, Ontario, M9C 4Z5, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G1V 4G5, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Bamberg, 96049, Germany

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Berlin, 10787, Germany

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Frankfurt, 60596, Germany

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Frankfurt am Main, 60389, Germany

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Hanover, 30173, Germany

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Neu-Isenburg, 63263, Germany

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Balassagyarmat, 2660, Hungary

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Komárom, 2900, Hungary

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Miskolc, 3529, Hungary

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Pécs, 7626, Hungary

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Pécs, 7635, Hungary

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Százhalombatta, 2440, Hungary

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Katowice, 40-954, Poland

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Mrągowo, 11-700, Poland

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Ostrów Wielkopolski, 63-400, Poland

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Pabianice, 95-200, Poland

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Poznan, 60-693, Poland

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Poznan, 60-823, Poland

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Tarnów, 33-100, Poland

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Wroclaw, 51-162, Poland

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Wroclaw, 53-301, Poland

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Bratislava, 821 06, Slovakia

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Bratislava, 851 01, Slovakia

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Humenné, 066 01, Slovakia

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Košice, 040 01, Slovakia

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Levice, 934 01, Slovakia

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Poprad, 058 01, Slovakia

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Prešov, 081 81, Slovakia

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Vráble, 952 01, Slovakia

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Žilina, 010 01, Slovakia

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Related Publications (1)

• Ferguson GT, FitzGerald JM, Bleecker ER, Laviolette M, Bernstein D, LaForce C, Mansfield L, Barker P, Wu Y, Jison M, Goldman M; BISE Study Investigators. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017 Jul;5(7):568-576. doi: 10.1016/S2213-2600(17)30190-X. Epub 2017 May 22.

  PMID: 28545978 BACKGROUND

Related Links

• CSP redacted

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 Leader Benralizumab
• Organization: AstraZeneca Research and Development

Mitchell.Goldman@astrazeneca.com

301 398 0323

Study Officials

• Gary T. Ferguson, M.D.,P.C.

  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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 23, 2014
• Study Start: February 2, 2015
• Primary Completion: October 7, 2015
• Study Completion: October 7, 2015
• Last Updated: August 15, 2017
• Results First Posted: February 14, 2017

Record last verified: 2017-08

Locations

DE (6); HU (6); PL (9); US (17); CA (10); SL (9)