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RESOLUTE: Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04053634
Collaborator
(none)
642
Enrollment
389
Locations
2
Arms
70
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL).

Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count.

The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.

Condition or Disease Intervention/Treatment Phase
  • Biological: Benralizumab
  • Biological: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
642 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official 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)
Actual Study Start Date :
Aug 26, 2019
Anticipated Primary Completion Date :
Jun 27, 2025
Anticipated Study Completion Date :
Jun 27, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Benralizumab

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

Biological: 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.
Placebo Comparator: Placebo

Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks

Biological: 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.

Outcome Measures

Primary Outcome Measures

  1. Annualized rate of moderate or severe COPD exacerbations [Over first 56 weeks]

    Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD

Secondary Outcome Measures

  1. Annualized rate of severe COPD exacerbations [Minimum of 1 year and an average of 2 years]

    A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD

  2. Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization [Minimum of 1 year and an average of 2 years]

  3. Time to first COPD exacerbation [During first 56 weeks]

  4. Change from baseline in SGRQ total and domain scores [up to 56 weeks]

    St. George's Respiratory Questionnaire (SGRQ)

  5. Change from baseline in E-RS:COPD total and domain scores [up to 56 weeks]

    Evaluating Respiratory Symptoms in COPD (E-RS:COPD)

  6. Change from baseline in pre-dose/pre-bronchodilator FEV1 [up to 56 weeks]

    FEV1 is the Forced expiratory volume in one second at study site

  7. All cause and respiratory-related mortality rate [Minimum of 1 year and an average of 2 years]

  8. Annual rate of hospitalizations due to COPD [Minimum of 1 year and an average of 2 years]

  9. Serum benralizumab concentration as a measure of pharmacokinetics [up to 56 weeks]

  10. Anti-drug antibodies (ADA) as a measure of immunogenicity [up to 56 weeks]

  11. Change from baseline in CAT total score [up to 56 weeks]

    Chronic Obstructive Pulmonary Disease assessment tool (CAT)

  12. Length of hospital stay [Minimum of 1 year and an average of 2 years]

  13. ICU (Intensive Care Unit) days [Minimum of 1 year and an average of 2 years]

  14. Annual rate of hospitalizations and emergency department visits combined [Minimum of 1 year and an average of 2 years]

  15. Annual rate of unscheduled outpatient visits including unscheduled visits to study sites [Minimum of 1 year and an average of 2 years]

  16. Annual rate of unscheduled healthcare encounters [Minimum of 1 year and and average of 2 years]

Other Outcome Measures

  1. Annualized rate of COPD-related events [up to 56 weeks]

    COPD-related event is defined by symptomatic worsening and increase in rescue medication as recorded in the eDiary

  2. Severity, frequency and duration of EXACT-PRO defined events [Up to 56 weeks]

    Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcome (EXACT-PRO)

  3. Clinically important deterioration [Up to 56 weeks]

    Clinically Important Deteriorations are defined as 100 mL decrease in pre-dose/pre-bronchodilator FEV1 compared to baseline, •Decline in health-related quality of life (≥4 unit increase in SGRQ total score compared to baseline), 1 moderate or severe on-treatment COPD exacerbation.

  4. Onset of effect of benralizumab [Up to 48 weeks]

    Patient perception of effect item from the Onset of Effect Questionnaire (OEQ)

  5. Total dose and number of days on systemic corticosteroids [Minimum of 1 year and average of 2 years]

  6. EQ-5D-5L [Minimum of 1 year and average of 2 years]

    European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)

  7. Change and percent change from baseline in peripheral blood eosinophil levels [Minimum of 1 year and average of 2 years]

    Peripheral blood eosinophil counts

  8. Safety and tolerability of benralizumab in patients with moderate to very severe COPD [Minimum of 1 year and average of 2 years]

    AEs, vital signs, clinical laboratory, and ECG

  9. Total rescue medication use [Minimum of 1 year and average of 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  7. Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.

  8. Hospitalization is defined as an inpatient admission ≥24 hours

  9. Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.

  10. At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.

  11. Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.

  12. 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.

  13. ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily.

  14. Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.

  15. Stable therapy/doses for the last 3 months prior to randomization.

  16. 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).

  17. CAT total score ≥15 at Visit 1.

  18. Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.

  19. 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).

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 any marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer.

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Montgomery Alabama United States 36116
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282 Research Site Chuo-ku Japan 103-0022
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316 Research Site Daegu Korea, Republic of 42415
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323 Research Site Guadalajara Mexico 44100
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331 Research Site Amersfoort Netherlands 3813 TZ
332 Research Site Breda Netherlands 4818 CK
333 Research Site Den Bosch Netherlands 5223 GZ
334 Research Site Den Haag Netherlands 2512 VA
335 Research Site Leeuwarden Netherlands 8934 AD
336 Research Site Auckland New Zealand 1051
337 Research Site Christchurch New Zealand 8013
338 Research Site Christchurch New Zealand 8024
339 Research Site Dunedin New Zealand 9016
340 Research Site Hamilton New Zealand 3204
341 Research Site Cavite City Philippines 4114
342 Research Site Iloilo City Philippines 5000
343 Research Site Los Baños Philippines 4030
344 Research Site Quezon City Philippines 1100
345 Research Site Białystok Poland 15-044
346 Research Site Katowice Poland 40-648
347 Research Site Poznań Poland 60-693
348 Research Site Poznań Poland 61-578
349 Research Site Proszowice Poland 32-100
350 Research Site Rzeszów Poland 35-051
351 Research Site Warszawa Poland 02-793
352 Research Site Wieluń Poland 98-300
353 Research Site Łódź Poland 90-153
354 Research Site Caguas Puerto Rico 00727
355 Research Site Barcelona Spain 08003
356 Research Site Hospitalet de Llobregat(Barcel Spain 08907
357 Research Site Laredo Spain 39770
358 Research Site Madrid Spain 28007
359 Research Site Madrid Spain 28046
360 Research Site Malaga Spain 29010
361 Research Site Santander Spain 39008
362 Research Site Göteborg Sweden 413 45
363 Research Site Göteborg Sweden 413 46
364 Research Site Helsingborg Sweden 25220
365 Research Site Lund Sweden 222 22
366 Research Site Malmö Sweden 205 02
367 Research Site Stockholm Sweden 114 46
368 Research Site Adana Turkey 01330
369 Research Site Ankara Turkey 06
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374 Research Site Mersin Turkey 33343
375 Research Site Barnsley United Kingdom S75 3DL
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382 Research Site Leicester United Kingdom LE3 9QP
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384 Research Site Newcastle-upon-Tyne United Kingdom NE1 4LP
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386 Research Site Perth United Kingdom PH1 1NX
387 Research Site Southampton United Kingdom SO166YD
388 Research Site Stockton-on-Tees United Kingdom TS17 6EW
389 Research Site Wishaw United Kingdom ML2 0DP

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: Gerard Criner, MD, Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04053634
Other Study ID Numbers:
  • D3251C00014
  • 2019-001800-39
First Posted:
Aug 12, 2019
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Chronic Obstructive Pulmonary Disease
COPD
benralizumab
Fasenra
ICS
inhaled corticosteroids
exacerbations
Lung Disease
LABA/LAMA
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Benralizumab

Study Results

No Results Posted as of Jul 21, 2022