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) (RESOLUTE)

  • End date
    Jun 27, 2025
  • participants needed
  • sponsor
Updated on 15 October 2022
eosinophil count
severe chronic obstructive pulmonary disease


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 Chronic Obstructive Pulmonary Disease
Treatment Placebo, benralizumab
Clinical Study IdentifierNCT04053634
Last Modified on15 October 2022


Yes No Not Sure

Inclusion Criteria

Provision of informed consent
Age 40 to 85 years
Male and/or female
Current or former smoker with a tobacco history of ≥10 pack-years
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value
Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment
Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization
Hospitalization is defined as an inpatient admission ≥24 hours
Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD
At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment
Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months
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
immediately prior to enrollment
Stable therapy/doses for the last 3 months prior to randomization
Total cumulative duration of not being on double or triple background therapy must not exceed 2 months
ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily
Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1
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
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)
CAT total score ≥15 at Visit 1
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

Clinically important pulmonary disease other than COPD
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
Cor pulmonale and/or right ventricular failure
and resolved before the age of 18
Radiological findings of a respiratory disease other than COPD contributing to
respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or
Known immunodeficiency disorder, including positive HIV-1/2 testing
findings of acute infection
Another pulmonary or systemic disease associated with elevated peripheral eosinophil
Any unstable disorder that could affect patient safety, study findings or the
Alcohol or drug abuse within the past year, which may compromise the study data
patient's ability to complete the study
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
Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while
breathing supplemental oxygen
Receipt of blood products or immunoglobulins within 30 days prior to randomization
Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of
History of anaphylaxis to any biologic therapy or vaccine
CPAP for Sleep Apnea Syndrome is allowed
Receipt of live attenuated vaccines 30 days prior to randomization
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
ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during
Receipt of benralizumab within 12 months prior to enrollment
the run-in period
Known history of allergy or reaction to any component of the IP formulation
Helminth parasitic infection within 24 weeks prior to enrollment, not treated or
failed to respond to standard of care therapy
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
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
Participation, or planned participation, in intensive COPD rehabilitation program
(maintenance phase of a rehabilitation is allowed)
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)
Scheduled major surgical procedure during the study. Minor elective procedures are
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
Chronic use of immunosuppressive medication or expected need for chronic use during
the study with marketed biologic products that are not likely to interfere with the
the study
safety assessment and/or efficacy of benralizumab, for example, for the treatment of
Chronic use of antibiotics if duration of treatment is <9 months prior to
osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic
randomization. Chronic macrolide or other antibiotic therapy is allowed provided the
diseases, can participate in the study
patient has been on stable dose/regimen for ≥9 months prior to randomization and has
had ≥2 COPD exacerbations while on stable therapy
Receipt of any investigational non-biologic product within 30 days or 5 half-lives
prior to enrollment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note