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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04053634




Registration number
NCT04053634
Ethics application status
Date submitted
16/07/2019
Date registered
12/08/2019

Titles & IDs
Public title
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
Scientific title
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
Secondary ID [1] 0 0
2019-001800-39
Secondary ID [2] 0 0
D3251C00014
Universal Trial Number (UTN)
Trial acronym
RESOLUTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Other - Benralizumab
Treatment: Other - Placebo

Experimental: Benralizumab - Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks

Placebo comparator: Placebo - Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks


Treatment: Other: Benralizumab
Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.

Treatment: Other: Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized rate of moderate or severe COPD exacerbations
Timepoint [1] 0 0
Over first 56 weeks
Secondary outcome [1] 0 0
Annualized rate of severe COPD exacerbations
Timepoint [1] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [2] 0 0
Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization
Timepoint [2] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [3] 0 0
Time to first COPD exacerbation
Timepoint [3] 0 0
During first 56 weeks
Secondary outcome [4] 0 0
Change from baseline in SGRQ total and domain scores
Timepoint [4] 0 0
up to 56 weeks
Secondary outcome [5] 0 0
Change from baseline in E-RS:COPD total and domain scores
Timepoint [5] 0 0
up to 56 weeks
Secondary outcome [6] 0 0
Change from baseline in pre-dose/pre-bronchodilator FEV1
Timepoint [6] 0 0
up to 56 weeks
Secondary outcome [7] 0 0
All cause and respiratory-related mortality rate
Timepoint [7] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [8] 0 0
Annual rate of hospitalizations due to COPD
Timepoint [8] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [9] 0 0
Serum benralizumab concentration as a measure of pharmacokinetics
Timepoint [9] 0 0
up to 56 weeks
Secondary outcome [10] 0 0
Anti-drug antibodies (ADA) as a measure of immunogenicity
Timepoint [10] 0 0
up to 56 weeks
Secondary outcome [11] 0 0
Change from baseline in CAT total score
Timepoint [11] 0 0
up to 56 weeks
Secondary outcome [12] 0 0
Length of hospital stay
Timepoint [12] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [13] 0 0
ICU (Intensive Care Unit) days
Timepoint [13] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [14] 0 0
Annual rate of hospitalizations and emergency department visits combined
Timepoint [14] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [15] 0 0
Annual rate of unscheduled outpatient visits including unscheduled visits to study sites
Timepoint [15] 0 0
Minimum of 1 year and an average of 2 years
Secondary outcome [16] 0 0
Annual rate of unscheduled healthcare encounters
Timepoint [16] 0 0
Minimum of 1 year and and average of 2 years

Eligibility
Key inclusion criteria
1. Provision of informed consent
2. Age 40 to 85 years
3. Male and/or female.
4. Current or former smoker with a tobacco history of =10 pack-years.
5. History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 =65% of predicted normal value.
6. Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.

1. Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.
2. Hospitalization is defined as an inpatient admission =24 hours
3. Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.
4. At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.
7. Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for =3 months immediately prior to enrollment.

1. Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.
2. ICS in a dose approved for COPD or equivalent to =250 mcg of fluticasone propionate daily.
3. Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.
4. Stable therapy/doses for the last 3 months prior to randomization.
8. Blood eosinophil count =300/µL at screening and documented historical eosinophil count of =150/µL within 52 weeks of enrollment (or repeated testing during run-in).
9. CAT total score =15 at Visit 1.
10. Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.
11. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.

Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically important pulmonary disease other than COPD
2. Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
3. Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
4. Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
5. Any unstable disorder that could affect patient safety, study findings or the patient's ability to complete the study.
6. Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient's ability to complete the study.
7. Cor pulmonale and/or right ventricular failure.
8. Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.
9. Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.
10. Known immunodeficiency disorder, including positive HIV-1/2 testing.
11. Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.
12. ALT or AST =3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
13. Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.
14. Alcohol or drug abuse within the past year, which may compromise the study data.
15. Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.
16. Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.
17. Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).
18. History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
19. Scheduled major surgical procedure during the study. Minor elective procedures are allowed.
20. History of anaphylaxis to any biologic therapy or vaccine.
21. Receipt of blood products or immunoglobulins within 30 days prior to randomization.
22. Receipt of marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.
23. Receipt of live attenuated vaccines 30 days prior to randomization.
24. Chronic use of immunosuppressive medication or expected need for chronic use during the study.
25. Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for =9 months prior to randomization and has had =2 COPD exacerbations while on stable therapy.
26. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.
27. Receipt of benralizumab within 12 months prior to enrollment.
28. Known history of allergy or reaction to any component of the IP formulation.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/08/2025
Actual
Sample size
Target
Accrual to date
Final
689
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Caringbah
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - South Brisbane
Recruitment hospital [4] 0 0
Research Site - Southport
Recruitment hospital [5] 0 0
Research Site - Spearwood
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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Country [172] 0 0
Japan
State/province [172] 0 0
Nishinomiya-shi
Country [173] 0 0
Japan
State/province [173] 0 0
Okayama-shi
Country [174] 0 0
Japan
State/province [174] 0 0
Osaka-shi
Country [175] 0 0
Japan
State/province [175] 0 0
Sagamihara-shi
Country [176] 0 0
Japan
State/province [176] 0 0
Sakai-shi
Country [177] 0 0
Japan
State/province [177] 0 0
Sakaide-shi
Country [178] 0 0
Japan
State/province [178] 0 0
Seto-shi
Country [179] 0 0
Japan
State/province [179] 0 0
Shinagawa-ku
Country [180] 0 0
Japan
State/province [180] 0 0
Toshima-ku
Country [181] 0 0
Japan
State/province [181] 0 0
Toyonaka-shi
Country [182] 0 0
Japan
State/province [182] 0 0
Ueda-shi
Country [183] 0 0
Japan
State/province [183] 0 0
Yanagawa-shi
Country [184] 0 0
Japan
State/province [184] 0 0
Yokohama-shi
Country [185] 0 0
Korea, Republic of
State/province [185] 0 0
Daegu
Country [186] 0 0
Korea, Republic of
State/province [186] 0 0
Jeonju-si
Country [187] 0 0
Korea, Republic of
State/province [187] 0 0
Seoul
Country [188] 0 0
Korea, Republic of
State/province [188] 0 0
Wonju-si
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Mexico
State/province [189] 0 0
Guadalajara
Country [190] 0 0
Mexico
State/province [190] 0 0
Mérida
Country [191] 0 0
Mexico
State/province [191] 0 0
Veracruz
Country [192] 0 0
Netherlands
State/province [192] 0 0
Breda
Country [193] 0 0
Netherlands
State/province [193] 0 0
Leeuwarden
Country [194] 0 0
New Zealand
State/province [194] 0 0
Auckland
Country [195] 0 0
New Zealand
State/province [195] 0 0
Christchurch
Country [196] 0 0
New Zealand
State/province [196] 0 0
Dunedin
Country [197] 0 0
New Zealand
State/province [197] 0 0
Hamilton
Country [198] 0 0
Philippines
State/province [198] 0 0
Iloilo City
Country [199] 0 0
Philippines
State/province [199] 0 0
Los Baños
Country [200] 0 0
Philippines
State/province [200] 0 0
Marilao
Country [201] 0 0
Philippines
State/province [201] 0 0
Quezon City
Country [202] 0 0
Poland
State/province [202] 0 0
Bialystok
Country [203] 0 0
Poland
State/province [203] 0 0
Checiny
Country [204] 0 0
Poland
State/province [204] 0 0
Grodzisk Mazowiecki
Country [205] 0 0
Poland
State/province [205] 0 0
Katowice
Country [206] 0 0
Poland
State/province [206] 0 0
Ostrowiec Swietokrzyski
Country [207] 0 0
Poland
State/province [207] 0 0
Poznan
Country [208] 0 0
Poland
State/province [208] 0 0
Proszowice
Country [209] 0 0
Poland
State/province [209] 0 0
Rzeszów
Country [210] 0 0
Poland
State/province [210] 0 0
Warszawa
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Poland
State/province [211] 0 0
Wielun
Country [212] 0 0
Poland
State/province [212] 0 0
Lódz
Country [213] 0 0
Spain
State/province [213] 0 0
Barcelona
Country [214] 0 0
Spain
State/province [214] 0 0
Hospitalet de Llobregat(Barcel
Country [215] 0 0
Spain
State/province [215] 0 0
Laredo
Country [216] 0 0
Spain
State/province [216] 0 0
Madrid
Country [217] 0 0
Spain
State/province [217] 0 0
Málaga
Country [218] 0 0
Spain
State/province [218] 0 0
Santander
Country [219] 0 0
Sweden
State/province [219] 0 0
Go¨teborg
Country [220] 0 0
Sweden
State/province [220] 0 0
Göteborg
Country [221] 0 0
Sweden
State/province [221] 0 0
Lund
Country [222] 0 0
Sweden
State/province [222] 0 0
Malmö
Country [223] 0 0
Sweden
State/province [223] 0 0
Stockholm
Country [224] 0 0
Turkey
State/province [224] 0 0
Adana
Country [225] 0 0
Turkey
State/province [225] 0 0
Istanbul
Country [226] 0 0
Turkey
State/province [226] 0 0
Izmir
Country [227] 0 0
Turkey
State/province [227] 0 0
Kocaeli
Country [228] 0 0
Turkey
State/province [228] 0 0
Mersin
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Barnsley
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Birmingham
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Blackpool
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Bradford
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Chertsey
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Cottingham
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Leicester
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Manchester
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Oxford
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Perth
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Southampton
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Stockton-on-Tees
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Wishaw
Country [242] 0 0
Vietnam
State/province [242] 0 0
Hanoi
Country [243] 0 0
Vietnam
State/province [243] 0 0
Ho Chi Minh city
Country [244] 0 0
Vietnam
State/province [244] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerard Criner, MD
Address 0 0
Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04053634