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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening period until eot db treatment period
Awards & highlights
DOMINICA Trial Summary
This trial tests a new treatment for severe asthma in children 6-18. It uses a new drug plus standard treatments to reduce asthma symptoms and attacks.
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.Check my eligibility
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.See study design
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.
DOMINICA Trial 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.
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I am between 6 and 17 years old.
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My asthma is linked to high eosinophil levels in my blood or lung tests.
Select...
My lung function test shows reduced airflow.
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My body weight is at least 15 kg.
DOMINICA Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first asthma exacerbation
Secondary outcome measures
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 outcome measures
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 • NCT0207525516%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo
DOMINICA 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 3
~10580
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,266 Previous Clinical Trials
288,605,782 Total Patients Enrolled
328 Trials studying Asthma
639,434 Patients Enrolled for Asthma
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,626 Total Patients Enrolled
20 Trials studying Asthma
39,895 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with the intake of Benralizumab?
"With a score of 3, Benralizumab has been evaluated to be safe as multiple rounds of research have supported the drug's efficacy and safety."
Answered by AI
Is the demographic of potential participants restricted to those above a certain age?
"This clinical trial permits applicants aged between 6 and 18. Clinicialtrials.gov currently lists 116 trials for individuals under the age of 18, as well as 194 studies aimed at those over 65 years old."
Answered by AI
Are there any vacancies for this experiment that prospective participants can fill?
"As per data on clinicaltrials.gov, this study is not currently accepting participants and the information has been recently updated as of January 11th 2023. For those still looking to participate in a medical trial, there are 315 other studies enrolling patients at present."
Answered by AI
What types of individuals are the ideal candidates for this experiment?
"This clinical trial is enrolling 200 adolescent patients, aged 6 to 18 years old, who suffer from asthma. To be eligible for consideration, participants must demonstrate their ability to give assent and have a caregiver that can provide written informed consent prior to commencement of the study. In addition, candidates should have had eosinophilic airway inflammation related to asthma (demonstrated by peripheral blood eosinophil count of ≥ 300 cells/μL during screening OR a blood eosinophil count of 150 - 299 cells/μL and documentation of elevated eosinophils in bronchoalveolar lav"
Answered by AI
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