NCT02918071: GRECO

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

Completed Phase 3 Results posted Last updated 2 November 2018

What this trial tests

Phase 3 trial testing Benralizumab in Asthma in 121 participants. Completed in 21 August 2017.

Timeline

10 November 2016

Primary endpoint
21 August 2017

21 August 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	121
Start date	10 November 2016
Primary completion	21 August 2017
Estimated completion	21 August 2017
Sites	25 locations across Canada, United States

Drugs / interventions tested

• Benralizumab (BENRALIZUMAB) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home Primary · Week 12, Week 16, Week 12 and 16

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

Group	Value	95% CI
Benra 30mg	113

Week 16

Group	Value	95% CI
Benra 30mg	112

Week 12 and 16

Group	Value	95% CI
Benra 30mg	108

Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional Primary · Week 12, Week 16

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

Week 12

Group	Value	95% CI
Benra 30mg	114

Week 16

Group	Value	95% CI
Benra 30mg	113

Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) Primary · Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16

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.

Week 0

Group	Value	95% CI
Benra 30mg	0

Week 4

Group	Value	95% CI
Benra 30mg	1

Week 8

Group	Value	95% CI
Benra 30mg	1

Week 12

Group	Value	95% CI
Benra 30mg	3

Week 16

Group	Value	95% CI
Benra 30mg	4

Week 0 to Week 8

Group	Value	95% CI
Benra 30mg	2

Week 12 to Week 16

Group	Value	95% CI
Benra 30mg	7

Week 0 to Week 16

Group	Value	95% CI
Benra 30mg	9

Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score Secondary · Week 0 (baseline) and weeks 4, 8, 12, 16, 20

The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicate

Week 4

Group	Value	95% CI
Benra 30mg	-0.63	± 0.99

Week 8

Group	Value	95% CI
Benra 30mg	-0.91	± 1.05

Week 12

Group	Value	95% CI
Benra 30mg	-1.07	± 1.02

Week 16

Group	Value	95% CI
Benra 30mg	-1.13	± 1.06

Week 20

Group	Value	95% CI
Benra 30mg	-1.04	± 1.08

The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab Secondary · Baseline, Week 8, Week 20, and Week 28

Mean PK Concentration at each visit

Baseline

Group	Value	95% CI
Benra 30mg	NA	± NA

Week 8

Group	Value	95% CI
Benra 30mg	698.18	± 186.455

Week 20

Group	Value	95% CI
Benra 30mg	787.51	± 280.788

Week 28

Group	Value	95% CI
Benra 30mg	62.86	± 469.359

The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels Secondary · Baseline, Week 20, and Week 28

Blood eosinophil counts by timepoint

Baseline

Group	Value	95% CI
Benra 30mg	230	150 – 360

Week 20

Group	Value	95% CI
Benra 30mg	20	10 – 30

Week 28

Group	Value	95% CI
Benra 30mg	20	10 – 50

The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA) Secondary · Baseline until Week 28

Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive

Positive at any visit

Group	Value	95% CI
Benra 30mg	9

Base- and Post-baseline Positive

Group	Value	95% CI
Benra 30mg	0

Only post-baseline positive

Group	Value	95% CI
Benra 30mg	9

Only baseline positive

Group	Value	95% CI
Benra 30mg	0

Persistently Positive

Group	Value	95% CI
Benra 30mg	8

Transiently Positive

Group	Value	95% CI
Benra 30mg	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 weeks.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Benra 30 mg

Serious: 1/121 (1%)

Deaths: 0/121

Serious adverse events (1 terms)

Reaction	System	Benra 30 mg
Asthma	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Benra 30 mg
Viral upper respiratory tract infection	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Headache	Nervous system disorders	—
Seasonal allergy	Immune system disorders	—
Bronchitis	Infections and infestations	—
Respiratory tract infection viral	Infections and infestations	—

Most-reported serious reactions: Asthma.

Data from ClinicalTrials.gov NCT02918071 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results.
   Ferguson GT, Cole J, Aurivillius M, Roussel P, et al · · 2019 · cited 14× · PMID 31695439 · DOI 10.2147/jaa.s224266