689 Participants Needed

Benralizumab for COPD

(RESOLUTE Trial)

Recruiting at 333 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: ICS/LABA/LAMA
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it requires that you continue your existing COPD treatment (triple therapy) for at least 3 months before joining the study.

Is benralizumab safe for humans?

Benralizumab has been approved for use in humans as a treatment for severe eosinophilic asthma, indicating it has undergone safety evaluations. While its safety for COPD specifically is still being studied, its approval for asthma suggests it is generally considered safe for human use.12345

What data supports the effectiveness of the drug benralizumab for COPD?

Benralizumab has been approved for treating severe eosinophilic asthma, which shares some characteristics with certain types of COPD, such as eosinophilia (high levels of a type of white blood cell). However, studies like GALATHEA and TERRANOVA did not show a significant reduction in COPD exacerbations with benralizumab compared to a placebo.12346

Who Is on the Research Team?

GC

Gerard Criner, MD

Principal Investigator

Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Total cumulative duration of not being on double or triple background therapy must not exceed 2 months
I use LABA/LAMA because I can't tolerate ICS.
I am between 40 and 85 years old.
See 24 more

Exclusion Criteria

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 use a CPAP machine for sleep apnea.
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive benralizumab or placebo subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks

56 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for long-term safety and efficacy outcomes

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Benralizumab
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Fasenra for:
🇺🇸
Approved in United States as Fasenra for:
🇨🇦
Approved in Canada as Fasenra for:
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Approved in Japan as Fasenra for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

Benralizumab (Fasenra™) is a monoclonal antibody that targets the interleukin-5 receptor alpha chain, specifically designed to treat severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD).
The drug has been approved by the US FDA as an add-on maintenance therapy for patients with severe asthma characterized by eosinophilia, highlighting its efficacy in depleting eosinophils, which are linked to asthma and COPD symptoms.
Benralizumab: First Global Approval.Markham, A.[2022]
In a study of 441 patients with severe asthma, 19% were found to be eligible for benralizumab treatment, indicating a significant subset of patients who may benefit from this therapy.
Patients eligible for benralizumab had poorer lung function and asthma control, experiencing more frequent exacerbations and hospitalizations, highlighting the need for effective treatment options in this population.
Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.Aubier, M., Thabut, G., Fabry-Vendrand, C.[2022]

Citations

Benralizumab for the Prevention of COPD Exacerbations. [2022]
Benralizumab: First Global Approval. [2022]
Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. [2022]
Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. [2020]
Does benralizumab effectively treat chronic obstructive pulmonary disease? A protocol of systematic review and meta-analysis. [2022]
Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. [2022]
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