Benralizumab for Asthma (DOMINICA Trial)
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests benralizumab, an injectable medication, in children and teenagers aged 6 to 18 with severe eosinophilic asthma. The medication works by reducing specific white blood cells that cause lung inflammation, helping to control asthma symptoms. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.
Is the drug Benralizumab a promising treatment for asthma?Yes, Benralizumab is a promising drug for treating severe asthma, especially for patients with a type of asthma called eosinophilic asthma. It has been approved for use and has shown benefits in reducing symptoms by targeting and reducing certain cells in the body that contribute to asthma.12469
What safety data exists for Benralizumab in treating asthma?Safety data for Benralizumab includes a Phase 1 study assessing its safety, tolerability, and pharmacokinetics in healthy Chinese participants. Additionally, the ANDHI study, a Phase IIIb, placebo-controlled trial, evaluated its efficacy and safety in patients with severe eosinophilic asthma.12467
What data supports the idea that Benralizumab for Asthma is an effective drug?The available research shows that Benralizumab is effective for treating severe asthma. It reduces asthma attacks and improves symptom control and quality of life. In one study, 36 patients treated with Benralizumab for a year showed improvement in their symptoms. Another study found that Benralizumab helped reduce the need for other asthma medications. Overall, these studies suggest that Benralizumab is a beneficial option for people with severe asthma.23578
Do I need to stop my current medications for this trial?The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on stable treatment for asthma with high-dose inhaled corticosteroids and at least one additional controller medication for at least 6 months prior to the trial. This suggests that you may continue your current asthma medications.
Eligibility Criteria
This trial is for children and teenagers aged 6 to under 18 with severe eosinophilic asthma. They must have a history of asthma exacerbations, be on high-dose inhaled corticosteroids plus another controller medication, and show certain levels of blood eosinophils. Females who can bear children must use effective contraception. Those with recent respiratory infections or steroid use, other significant health issues, or previous benralizumab treatment are excluded.Inclusion Criteria
I have had severe asthma attacks needing steroids or hospital visits.
I am between 6 and 17 years old.
My asthma is linked to high eosinophil levels in my blood or lung tests.
My lung function test shows reduced airflow.
My body weight is at least 15 kg.
Exclusion Criteria
I have severe asthma that could endanger my life.
I have or had cancer.
I haven't needed steroids for asthma or had a serious respiratory infection in the last 2 weeks.
I have been treated with benralizumab before.
I am currently taking medication that suppresses my immune system.
I have a worm infection.
Treatment Details
The study tests the effectiveness and safety of benralizumab given by injection compared to a placebo in managing severe eosinophilic asthma in young patients. It focuses on reducing the number of asthma attacks (exacerbations) while monitoring any potential side effects from the treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Patients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive a matching solution of the placebo via SC injection.
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 nearbySelect from list below to view details:
Research SiteBurlington, Canada
Research SiteCharleston, SC
Research SiteLittle Rock, AR
Research SiteQuebec, Canada
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
ParexelIndustry Sponsor
References
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.
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.
Identification of distinct phenotypes related to benralizumab responsiveness in patients with severe eosinophilic asthma. [2021]To characterize the clinical phenotypes of severe eosinophilic asthma based on early responsiveness to benralizumab in terms of forced expiratory volume in 1 second (FEV1) improvement.
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.
Real world effectiveness of benralizumab on respiratory function and asthma control. [2022]Biological drugs have been recognized as a breakthrough in the treatment of severe refractory asthma. This retrospective real-life observational study aims to evaluate the effect of add-on benralizumab on lung function, exacerbation rate, oral corticosteroids (OCS) reduction and asthma control questionnaire (ACQ) score after 52-weeks.
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.
Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy. [2023]The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy.
Pretreatment Frequency of Circulating Th17 Cells and FeNO Levels Predicted the Real-World Response after 1 Year of Benralizumab Treatment in Patients with Severe Asthma. [2023]Benralizumab treatment reduces exacerbations and improves symptom control and quality of life in patients with severe eosinophilic asthma. However, the determination of biomarkers that predict therapeutic effectiveness is required for precision medicine. Herein, we elucidated the dynamics of various parameters before and after treatment as well as patient characteristics predictive of clinical effectiveness after 1 year of benralizumab treatment in severe asthma in a real-world setting. Thirty-six patients with severe asthma were treated with benralizumab for 1 year. Lymphocyte subsets in peripheral blood samples were analyzed using flow cytometry. Treatment effectiveness was determined based on the ACT score, forced expiratory volume in 1 s (FEV1), and the number of exacerbations. Benralizumab provided symptomatic improvement in severe asthma. Benralizumab significantly decreased peripheral blood eosinophil and basophil counts and the frequencies of regulatory T cells (Tregs), and increased the frequencies of Th2 cells. To our knowledge, this is the first study to show benralizumab treatment increasing circulating Th2 cells and decreasing circulating Tregs. Finally, the ROC curve to discriminate patients who achieved clinical effectiveness of benralizumab treatment revealed that the frequency of circulating Th17 cells and FeNO levels might be used as parameters for predicting the real-world response of benralizumab treatment in patients with severe asthma.
Real-World Effectiveness Study of Benralizumab for Severe Eosinophilic Asthma: ZEPHYR 2. [2023]Benralizumab is an mAb therapy for severe eosinophilic asthma. Real-world data on its clinical impact in various patient populations such as patients with varying eosinophil levels, previous biologic use, and extended follow-up in the United States are limited.