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Monoclonal Antibodies
Benralizumab for Asthma (DOMINICA Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) within 12 months prior to Visit 1, OR, 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) per year within the 2 years prior to Visit 1 AND, one or more of the following: Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR, At least one of the 2 exacerbations that occurred in the year prior to Visit 1 resulted in hospitalisation.
Male or female patients aged ≥ 6 to < 18 years old.
Must not have
Life-threatening asthma
Current malignancy, or history of malignancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening period until eot db treatment period
Awards & highlights
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include allergic reactions to the drug's components which could range from mild skin reactions to more serious conditions like anaphylaxis. As it's an immune-modulating therapy, there may also be increased risks of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe asthma attacks needing steroids or hospital visits.
Select...
I am between 6 and 17 years old.
Select...
My asthma is linked to high eosinophil levels in my blood or lung tests.
Select...
My lung function test shows reduced airflow.
Select...
My body weight is at least 15 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe asthma that could endanger my life.
Select...
I have or had cancer.
Select...
I haven't needed steroids for asthma or had a serious respiratory infection in the last 2 weeks.
Select...
I have been treated with benralizumab before.
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I am currently taking medication that suppresses my immune system.
Select...
I have a worm infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during day -7, day 56, day 112, every 16 weeks and at eot db treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during day -7, day 56, day 112, every 16 weeks and at eot db treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to first asthma exacerbation
Secondary study objectives
Anti-benralizumab antibodies
Change from baseline, during the DB treatment period in Asthma symptom score
Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA)
+8 moreOther study objectives
Number of patients with Adverse events (AEs) and Serious adverse events (SAEs)
The AAER in the OLE period
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments work through various mechanisms to reduce inflammation, relax airway muscles, and prevent exacerbations. Biologics like benralizumab target specific pathways involved in asthma.
Benralizumab is an anti-IL-5 receptor monoclonal antibody that reduces eosinophils, which are white blood cells that contribute to inflammation and asthma severity. By lowering eosinophil levels, benralizumab helps decrease asthma exacerbations and improve lung function.
Other common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, long-acting beta-agonists (LABA) that relax airway muscles, and leukotriene modifiers that block inflammatory chemicals. These treatments are crucial for managing asthma symptoms, preventing attacks, and improving the quality of life for asthma patients.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,375 Previous Clinical Trials
288,738,543 Total Patients Enrolled
346 Trials studying Asthma
661,166 Patients Enrolled for Asthma
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,688 Total Patients Enrolled
20 Trials studying Asthma
39,777 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to benralizumab or any of the ingredients in the medication.You have had a severe allergic reaction to any biologic medication in the past.I have had severe asthma attacks needing steroids or hospital visits.I can sign the consent form, and my caregiver can give consent for me.I am between 6 and 17 years old.I have severe asthma that could endanger my life.My asthma is linked to high eosinophil levels in my blood or lung tests.My lung function test shows reduced airflow.I have a lung condition that is not asthma, affecting my eosinophil counts.I have or had cancer.I haven't taken any experimental or approved biologic drugs recently.I have been diagnosed and treated for severe asthma for at least 6 months.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 use reliable birth control methods if I can have children and am sexually active.I have not received immunoglobulin or blood products in the last 30 days.I am currently taking medication that suppresses my immune system.You have taken at least 70% of your asthma medication as prescribed during the screening period.My body weight is at least 15 kg.I have a worm infection.I have been on a stable, high-dose asthma treatment plan for at least 6 months.I have been diagnosed with eosinophilic asthma for at least a year.Your asthma symptoms are not improving despite treatment.
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.
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