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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02155660
Registration number
NCT02155660
Ethics application status
Date submitted
20/05/2014
Date registered
4/06/2014
Date last updated
26/06/2019
Titles & IDs
Public title
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
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Scientific title
A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
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Secondary ID [1]
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D3251C00004
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Universal Trial Number (UTN)
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Trial acronym
TERRANOVA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Benralizumab Arm A
Treatment: Drugs - Benralizumab Arm B
Treatment: Drugs - Benralizumab Arm C
Treatment: Drugs - Placebo
Experimental: Benralizumab Arm A - Benralizumab administered subcutaneously
Experimental: Benralizumab Arm B - Benralizumab administered subcutaneously
Experimental: Benralizumab Arm C - Benralizumab administered subcutaneously
Placebo Comparator: Placebo - Placebo administered subcutaneously
Treatment: Drugs: Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Treatment: Drugs: Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Treatment: Drugs: Benralizumab Arm C
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Treatment: Drugs: Placebo
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
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Assessment method [1]
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A COPD exacerbation is defined by symptomatic worsening of COPD requiring:
Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
Use of antibiotics; and/or
An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
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Timepoint [1]
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Immediately following the first IP dose through week 56
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Secondary outcome [1]
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Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
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Assessment method [1]
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A COPD exacerbation is defined by symptomatic worsening of COPD requiring:
Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
Use of antibiotics; and/or
An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
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Timepoint [1]
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Immediately following the first IP dose through week 56
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Secondary outcome [2]
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Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
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Assessment method [2]
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Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.
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Timepoint [2]
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First IP up to end of treatment Week 56
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Secondary outcome [3]
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Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
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Assessment method [3]
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SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.
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Timepoint [3]
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First IP up to Week 56
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Secondary outcome [4]
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Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
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Assessment method [4]
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CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.
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Timepoint [4]
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First IP up to Week 56
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Secondary outcome [5]
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Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
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Assessment method [5]
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The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.
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Timepoint [5]
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First IP up to Week 56
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Secondary outcome [6]
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Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
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Assessment method [6]
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The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.
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Timepoint [6]
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First IP up to Week 56
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Secondary outcome [7]
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Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
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Assessment method [7]
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Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.
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Timepoint [7]
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First IP up to Week 56
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Secondary outcome [8]
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Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
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Assessment method [8]
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The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score =9 for 3 days or =12 for 2 days indicates a COPD exacerbation event has occurred.
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Timepoint [8]
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Immediately following first IP up to week 56
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Secondary outcome [9]
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Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
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Assessment method [9]
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The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.
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Timepoint [9]
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Immediately following first IP up to week 56
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Secondary outcome [10]
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Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
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Assessment method [10]
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The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score =9 for 3 days or =12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.
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Timepoint [10]
0
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Immediately following first IP up to week 56
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Secondary outcome [11]
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Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
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Assessment method [11]
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The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score =9 for 3 days or =12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
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Timepoint [11]
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Immediately following the first IP dose through week 56
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Secondary outcome [12]
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Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
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Assessment method [12]
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A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.
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Timepoint [12]
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Immediately following first IP dose up to week 56
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Secondary outcome [13]
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Time to First COPD Exacerbation
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Assessment method [13]
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Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.
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Timepoint [13]
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Immediately following IP dose to Week 56
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Secondary outcome [14]
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Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
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Assessment method [14]
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Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
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Timepoint [14]
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Immediately following the first IP dose through week 56
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Secondary outcome [15]
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Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
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Assessment method [15]
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Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.
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Timepoint [15]
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Immediately following first IP dose up to Week 56
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Secondary outcome [16]
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Duration of Study Treatment Administration
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Assessment method [16]
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Duration of study treatment is calculated from first dose date to last dose date + 1 day.
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Timepoint [16]
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From first dose date to last dose date, 48 weeks per protocol.
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Secondary outcome [17]
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Serum Concentration of Benralizumab
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Assessment method [17]
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PK serum samples were collected pre-dose at each visit.
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Timepoint [17]
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Pre-first dose and pre-dose at end of treatment (week 56).
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Secondary outcome [18]
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Immunogenicity of Benralizumab
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Assessment method [18]
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Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.
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Timepoint [18]
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Pre-treatment until end of follow-up, week 60 per protocol.
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Eligibility
Key inclusion criteria
.
- Informed consent.
- Subjects 40-85 y.o.
- Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and =65%.
-=2 moderate or =1 severe COPD exacerbation(s) required treatment or hospitalization
within 2-52 weeks prior to Visit1.
- Modified Medical Research Council (mMRC) score =1 at Visit 1.
- Treatment with double or triple therapy throughout the year prior to Visit 1, constant
2 weeks prior to Visit 1.
- Tobacco history of =10 pack-years.
- Women of childbearing potential must use a highly effective form of birth control from
Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result
at Visit 1.
- Male subjects who are sexually active must be surgically sterile one year prior to
Visit 1 or use an adequate method of contraception from the first Investigational
Product (IP) dose until 16 weeks after their last dose.
- Compliance with maintenance therapy during run-in =70%.
- Blood eosinophils due to subject's stratification and cap for blood eosinophil
levels.When any eosinophil cohort is full, subjects in the completed cohort will not
be randomised and will be withdrawn from the study.
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Minimum age
40
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Clinically important pulmonary disease other than COPD or another diagnosed pulmonary
or systemic disease associated with elevated peripheral eosinophil counts.
- Any disorder or major physical impairment that is not stable by Investigator opinion
and/or could affect: - subject safety-study findings or their interpretation or
subject's ability to complete the entire study duration.
- Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant
cardiovascular disorder that in Investigator's judgment may put the patient at risk or
negatively affect the study outcome.
- Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for
a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in
period.
- Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior
to Visit1 or during the enrolment and run-in period.
- Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
- Pregnant, breastfeeding, or lactating women.
- Risk factors for pneumonia
- History of anaphylaxis to any other biologic therapy.
- Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right
ventricular failure.
- Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the
enrolment and run-in period.
- Receipt of any investigational non-biologic product within 30 days or 5 half-lives
prior to Visit 1.
- Evidence of active tuberculosis (TB) without an appropriate course of treatment.
- Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial
or total lung resection (single lobe or segmentectomy is acceptable).
- Asthma as a primary or main diagnosis according to the Global Initiative for Asthma
(GINA) guidelines or other accepted guidelines.
- Previous treatment with benralizumab.
- Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/06/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/04/2018
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Sample size
Target
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Accrual to date
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Final
2255
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Recruitment hospital [2]
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Research Site - Gosford
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Recruitment hospital [3]
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Research Site - Murdoch
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Research Site - Nedlands
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Recruitment hospital [5]
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Research Site - New Lambton
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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2250 - Gosford
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6150 - Murdoch
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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2310 - New Lambton
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment outside Australia
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Caba
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Brazil
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Brazil
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Brazil
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Bulgaria
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Medillin
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Næstved
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Denmark
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Odense C
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Silkeborg
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France
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France
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France
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France
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Marseille
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France
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France
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NIMES Cedex 9
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France
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Orléans Cedex 2
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France
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Pessac
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Israel
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Rehovot
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Israel
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Mexico
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Mexico
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Mexico
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Greenlane
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New Zealand
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Hamilton West
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New Zealand
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Tauranga
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Svelvik
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Peru
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Lima
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Piura
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Lund
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Thailand
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Muang,
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Bursa
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Lutsk
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Lviv
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Odesa
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Vinnytsia
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Zaporizhzhya
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Vietnam
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Can Tho
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Hanoi
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
MedImmune LLC
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Address [1]
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0
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in
symptomatic patients with moderate to very severe COPD who are receiving standard of care
therapies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02155660
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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0
0
Bartolome R. Celli, MD
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Address
0
0
Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02155660
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