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Monoclonal Antibodies
Benralizumab for COPD (RESOLUTE Trial)
Phase 3
Waitlist Available
Led By Gerard Criner, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40 to 85 years
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value
Must not have
Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment
Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 1 year and average of 2 years
Awards & highlights
Pivotal Trial
Summary
This trial will evaluate the efficacy and safety of benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils.
Who is the study for?
Adults aged 40-85 with moderate to very severe COPD, a history of frequent exacerbations despite ongoing triple therapy, and elevated blood eosinophils can join. They must have smoked at least 10 pack-years. Excluded are those with unstable disorders, other significant lung diseases like asthma, oxygen needs over 4 L/min, certain liver diseases or infections, recent use of certain drugs or biologics.
What is being tested?
The trial is testing the effectiveness and safety of Benralizumab compared to a placebo in patients with COPD who frequently experience flare-ups. Participants will receive treatment for at least 56 weeks to see if it reduces these exacerbations.
What are the potential side effects?
Potential side effects include common cold symptoms, headache, sore throat and reactions at the injection site such as pain or swelling. There may also be risks related to allergic reactions including anaphylaxis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 85 years old.
Select...
I have COPD with specific breathing test results.
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I had a severe COPD flare-up while on continuous triple therapy before joining.
Select...
I am taking a daily inhaler for COPD equivalent to or more than 250 mcg of fluticasone.
Select...
I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.
Select...
I am a woman who cannot become pregnant because I am either sterilized or have gone through menopause.
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I have been on a double inhaled therapy including steroids for the last year.
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I have severe COPD with specific breathing test results.
Select...
I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.
Select...
I have smoked at least 10 pack-years.
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My medication doses have been stable for the last 3 months.
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I am not pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken any experimental drugs within the last 30 days or 5 half-lives.
Select...
I need more than 4 liters per minute of oxygen or my oxygen levels stay below 89% even with extra oxygen.
Select...
I regularly take medication that affects my immune system.
Select...
I have had lung surgery or a procedure to reduce lung volume in the last 6 months.
Select...
I have a condition that increases my eosinophil count.
Select...
I have not taken benralizumab in the last 12 months.
Select...
I have a significant lung condition that is not COPD.
Select...
I had a worm infection in the last 6 months that wasn't cured by standard treatments.
Select...
I have a stable chronic liver condition, including hepatitis B or C.
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I have lung problems not caused by COPD, including nodules or infections.
Select...
I have heart issues related to lung disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum of 1 year and average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 1 year and average of 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annualized rate of moderate or severe COPD exacerbations
Secondary study objectives
Annualized rate of severe COPD exacerbations
Change from baseline in CAT total score
Change from baseline in E-RS:COPD total and domain scores
+2 moreOther study objectives
Safety and tolerability of benralizumab in patients with moderate to very severe COPD
Side effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525515%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Benra 30 mg q.8 Weeks
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10320
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,120,968 Total Patients Enrolled
Gerard Criner, MDPrincipal InvestigatorTemple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
9 Previous Clinical Trials
5,172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use LABA/LAMA because I can't tolerate ICS.I haven't taken any experimental drugs within the last 30 days or 5 half-lives.I need more than 4 liters per minute of oxygen or my oxygen levels stay below 89% even with extra oxygen.I am between 40 and 85 years old.I use a CPAP machine for sleep apnea.I regularly take medication that affects my immune system.Your CAT total score is 15 or higher at the first visit.I have COPD with specific breathing test results.I had a severe COPD flare-up while on continuous triple therapy before joining.I have had lung surgery or a procedure to reduce lung volume in the last 6 months.I have a condition that increases my eosinophil count.I am enrolled or planning to enroll in an intensive COPD rehab program.I am not scheduled for any major surgeries during the study, but minor ones are okay.I have not taken benralizumab in the last 12 months.I have a significant lung condition that is not COPD.You had a severe allergic reaction to any biologic therapy or vaccine in the past.I've been on a stable dose of antibiotics for over 9 months due to COPD exacerbations.I haven't taken any new biologic drugs recently, except for stable treatments for conditions like osteoporosis or diabetes.I have not received blood products or immunoglobulins in the last 30 days.I have not received any live vaccines in the last 30 days.Your blood has a high level of eosinophils, a type of white blood cell, both during the screening and in the past year.My flare-ups only count if I took steroids or was hospitalized, not just antibiotics.I am either male or female.I had a worm infection in the last 6 months that wasn't cured by standard treatments.I don't have any health issues that could risk my safety in the study.I have a stable chronic liver condition, including hepatitis B or C.My flare-ups were serious enough to need steroids or hospital care.I have lung problems not caused by COPD, including nodules or infections.I am taking a daily inhaler for COPD equivalent to or more than 250 mcg of fluticasone.I have heart issues related to lung disease.I have asthma, or had it as a child, or have asthma-COPD overlap.I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.I am a woman who cannot become pregnant because I am either sterilized or have gone through menopause.I have been on a double inhaled therapy including steroids for the last year.You have smoked a pack of cigarettes every day for at least 10 years.I have severe COPD with specific breathing test results.My COPD worsened even though I was on stable triple therapy.I have been admitted to the hospital for at least 24 hours.Your CAT total score is 15 or higher at Visit 1.I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.You have a condition that weakens your immune system, like HIV.Your liver enzymes (ALT or AST) are more than three times the normal level, as confirmed by multiple tests.You have had problems with drinking too much alcohol or using drugs in the past year, which could affect the study results.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer treated over a year ago.I do not have active tuberculosis or have completed treatment if recently tested positive.I have smoked at least 10 pack-years.I am either male or female.My medication doses have been stable for the last 3 months.I have been on triple therapy for COPD for at least 3 months.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Benralizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04053634 — Phase 3
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