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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
D3251C00004
Universal Trial Number (UTN)
Trial acronym
TERRANOVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Very Severe Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [1] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [1] 0 0
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
Timepoint [1] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [2] 0 0
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Timepoint [2] 0 0
First IP up to end of treatment Week 56
Secondary outcome [3] 0 0
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
Timepoint [3] 0 0
First IP up to Week 56
Secondary outcome [4] 0 0
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
Timepoint [4] 0 0
First IP up to Week 56
Secondary outcome [5] 0 0
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
Timepoint [5] 0 0
First IP up to Week 56
Secondary outcome [6] 0 0
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
Timepoint [6] 0 0
First IP up to Week 56
Secondary outcome [7] 0 0
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Timepoint [7] 0 0
First IP up to Week 56
Secondary outcome [8] 0 0
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
Timepoint [8] 0 0
Immediately following first IP up to week 56
Secondary outcome [9] 0 0
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
Timepoint [9] 0 0
Immediately following first IP up to week 56
Secondary outcome [10] 0 0
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
Timepoint [10] 0 0
Immediately following first IP up to week 56
Secondary outcome [11] 0 0
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [11] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [12] 0 0
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
Timepoint [12] 0 0
Immediately following first IP dose up to week 56
Secondary outcome [13] 0 0
Time to First COPD Exacerbation
Timepoint [13] 0 0
Immediately following IP dose to Week 56
Secondary outcome [14] 0 0
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [14] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [15] 0 0
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Timepoint [15] 0 0
Immediately following first IP dose up to Week 56
Secondary outcome [16] 0 0
Duration of Study Treatment Administration
Timepoint [16] 0 0
From first dose date to last dose date, 48 weeks per protocol.
Secondary outcome [17] 0 0
Serum Concentration of Benralizumab
Timepoint [17] 0 0
Pre-first dose and pre-dose at end of treatment (week 56).
Secondary outcome [18] 0 0
Immunogenicity of Benralizumab
Timepoint [18] 0 0
Pre-treatment until end of follow-up, week 60 per protocol.

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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2018
Sample size
Target
Accrual to date
Final
2255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - New Lambton
Recruitment hospital [6] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2310 - New Lambton
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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Alabama
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Chernivtsi
Country [184] 0 0
Ukraine
State/province [184] 0 0
Dnipropetrovsk
Country [185] 0 0
Ukraine
State/province [185] 0 0
Ivano-Frankivsk
Country [186] 0 0
Ukraine
State/province [186] 0 0
Kharkiv
Country [187] 0 0
Ukraine
State/province [187] 0 0
Kyiv
Country [188] 0 0
Ukraine
State/province [188] 0 0
Lutsk
Country [189] 0 0
Ukraine
State/province [189] 0 0
Lviv
Country [190] 0 0
Ukraine
State/province [190] 0 0
Odesa
Country [191] 0 0
Ukraine
State/province [191] 0 0
Vinnytsia
Country [192] 0 0
Ukraine
State/province [192] 0 0
Zaporizhzhya
Country [193] 0 0
Vietnam
State/province [193] 0 0
Can Tho
Country [194] 0 0
Vietnam
State/province [194] 0 0
Hanoi
Country [195] 0 0
Vietnam
State/province [195] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MedImmune LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02155660
Trial related presentations / publications
Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Public notes

Contacts
Principal investigator
Name 0 0
Bartolome R. Celli, MD
Address 0 0
Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02155660