Benralizumab for Asthma

(CHINOOK Trial)

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen by Mario Castro, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: AstraZeneca

Must be taking: Inhaled corticosteroids, Long acting B2-agonist

Must not be taking: Immunosuppressives, Biologics

Disqualifiers: Current smokers, Cancer, Life-threatening asthma, others

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must be on a high-dose inhaled corticosteroid plus a long-acting B2-agonist for at least 3 months before joining the trial.

What data supports the effectiveness of the drug Benralizumab for asthma?

Research shows that Benralizumab can significantly reduce asthma attacks and improve lung function in patients with severe asthma. It works by targeting and reducing eosinophils, a type of white blood cell that can cause inflammation in asthma. ^{1 2 3 4 5}

Is Benralizumab safe for humans?

Benralizumab, also known as Fasenra, has been shown to be generally safe and well-tolerated in clinical trials for severe eosinophilic asthma. Studies have demonstrated its safety in both healthy individuals and patients with asthma, with no major safety concerns reported. ^{1 2 6 7 8}

How is the drug Benralizumab different from other asthma treatments?

Benralizumab is unique because it is a monoclonal antibody that targets the interleukin-5 receptor, which helps reduce the number of eosinophils (a type of white blood cell involved in inflammation) in the body. This makes it particularly effective for patients with severe eosinophilic asthma, a type of asthma that is not well controlled by standard treatments like inhaled corticosteroids and long-acting beta-agonists. ^{1 2 3 6 9}

Research Team

Mario Castro, MD

Principal Investigator

University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA

Eligibility Criteria

Adults aged 18-70 with severe eosinophilic asthma, not well-controlled despite using inhaled steroids and long-acting beta agonists. They must have specific levels of blood eosinophils and less than 12 asthma attacks in the past six months. Excluded are those who've had certain treatments like benralizumab or bronchial thermoplasty recently, current smokers, cancer patients, pregnant women, or those on immunosuppressants.

Inclusion Criteria

I've had fewer than 12 asthma attacks in the last 6 months.

My blood test shows I have high eosinophils, or I have nasal polyps, or my lung function is reduced.

I've had fewer than 12 flare-ups of my condition in the last 6 months.

Exclusion Criteria

I haven't taken immunosuppressive drugs or received blood products in the last 30 days.

Currently pregnant, breastfeeding or lactating women.

I haven't had certain asthma treatments or vaccines recently.

Trial Timeline

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 over a 48-week period

48 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Benralizumab (Monoclonal Antibodies)

Trial Overview The trial is testing if benralizumab can improve lung structure and function over a 48-week period compared to a placebo in patients with severe eosinophilic asthma. Participants will be monitored for changes after treatment and during a four-week follow-up.

Participant Groups

Group I: Benralizumab Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

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

🇪🇺 Approved in European Union as Fasenra for:

• Severe eosinophilic asthma

🇺🇸 Approved in United States as Fasenra for:

• Severe asthma with an eosinophilic phenotype

🇨🇦 Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

🇯🇵 Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Saint Cloud, FL

Research Site Bloomfield Hills, MI

Research Site Lewisville, TX

Research Site Galveston, TX

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. [2022] Label="BACKGROUND AND OBJECTIVE" NlmCategory="OBJECTIVE">Benralizumab (Fasenra™) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting β2-agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab.

2. New Zealand pubmed.ncbi.nlm.nih.gov

Benralizumab: First Global Approval. [2022] Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)-a humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) monoclonal antibody-as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype. This article summarizes the milestones in the development of benralizumab leading to this first approval for the treatment of severe eosinophilic asthma.

3. Spain pubmed.ncbi.nlm.nih.gov

Benralizumab for the treatment of asthma. [2018] Benralizumab is a humanized monoclonal antibody directed at the a subunit of the interleukin-5 receptor (IL-5R) that is under clinical development. The binding of benralizumab with the alpha chain of IL-5R results in inhibition of hetero-oligomerization of alpha and beta subunits and thus no signal transduction occurs. Consequently, this inhibition prevents proliferation of eosinophils and basophils and the cascade of events following it. Several pivotal trials have documented that benralizumab reduces asthma exacerbation rates with a significant increase in time to the next exacerbation, statistically improves prebronchodilator forced expiratory volume in 1 second (FEV1) and disease-specific health-related quality of life, and is well tolerated in patients with severe asthma and blood eosinophil counts greater than or equal to 150 cells/mcL.

4. China pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of benralizumab for severe asthma in clinical practice (J-BEST): a prospective study. [2022] Benralizumab is a humanized, fucosylated, monoclonal antibody that targets the interleukin 5 (IL-5) α receptor. Several phase III trials have shown that benralizumab can significantly reduce the incidence of acute exacerbations and improve lung function in patients with severe asthma. However, there is a paucity of data from clinical practice. In this prospective study, we evaluated the effectiveness and safety of benralizumab for severe asthma in clinical practice.

5. England pubmed.ncbi.nlm.nih.gov

Blood eosinophil count and FeNO to predict benralizumab effectiveness in real-life severe asthma patients. [2022] Benralizumab is a promising drug for severe uncontrolled asthma. This study aimed to clarify the effectiveness of benralizumab in a real-life setting.

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Benralizumab: A Phase 1, Randomized, Single-Blind Study of Healthy Chinese Participants. [2023] Label="Purpose" NlmCategory="UNASSIGNED">Biological therapies targeting eosinophils have been shown to be effective in treating patients with severe eosinophilic asthma. Benralizumab (Fasenra®, AstraZeneca) is a humanized monoclonal antibody binding to the alpha subunit of the interleukin-5 receptor, which rapidly depletes eosinophils via antibody-dependent cellular cytotoxicity. The aim of this Phase 1 study was to assess the safety, tolerability, and pharmacokinetics of benralizumab in healthy Chinese individuals.

7. England pubmed.ncbi.nlm.nih.gov

ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. [2022] Data from phase 3 trials have demonstrated the efficacy and safety of benralizumab in patients with severe eosinophilic asthma (SEA). We conducted a real-world study examining the baseline characteristics of a large SEA population treated with benralizumab in clinical practice and assessed therapy effectiveness.

8. England pubmed.ncbi.nlm.nih.gov

Benralizumab: an updated treatment of eosinophilic asthma. [2021] Introduction: An estimated 5-10% of people with asthma have disease which remains uncontrolled despite maximal treatment with inhaled corticosteroids and long-acting beta-agonists. Benralizumab is currently licensed for use in patients with severe asthma who have an eosinophilic phenotype. Benralizumab depletes eosinophils by binding to the anti-IL5 receptor on the surface of eosinophils, mitigating the effect of IL-5 on eosinophil proliferation and survival, and induces natural killer cell-mediated eosinophil apoptosis.Areas covered: The authors review the mechanism of action and pharmacokinetic profile of Benralizumab and summarize the scientific data supporting its clinical efficacy and safety in severe asthma. Further, the authors highlight future studies of Benralizumab in asthma and other diseases.Expert opinion: Benralizumab lowers exacerbation rates, symptom burden, and oral glucocorticoid use, and improves lung function, in patients with severe eosinophilic asthma. Benralizumab is well tolerated and is an attractive choice for patients and physicians due to its eosinophil-depleting mechanism of action and less frequent dosing schedule. More data is needed to guide the selection of biologic therapy in severe asthma patients.

9. United States pubmed.ncbi.nlm.nih.gov

Histological remission of eosinophilic esophagitis under asthma therapy with IL-5 receptor monoclonal antibody: A case report. [2022] Benralizumab is a monoclonal antibody targeting the IL-5 receptor used in the treatment of asthma. The use of benralizumab in other conditions is only emerging and could represent a therapeutic option for other eosinophil-associated diseases. Here, we report the case of a patient suffering from eosinophilic esophagitis and asthma who achieved histological remission of eosinophilic esophagitis (EoE) under benralizumab treatment for his asthma.