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Monoclonal Antibodies
Dupilumab for Asthma (IDEA Trial)
Phase 4
Recruiting
Led By Wanda Phipatanakul
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants of childbearing potential must have a negative urine pregnancy test upon study entry
Treatment with medium to high dose ICS (400 mcg to maximum of 2000 mcg per day of fluticasone propionate or equivalent) for at least 3 months with a stable dose ≥1 month prior to screening OR used a biologic medication for asthma within the past 8 weeks
Must not have
History of respiratory illness requiring antibiotics or systemic corticosteroids, including asthma exacerbations, within the past 4 weeks (evaluated at time of screening visit)
Chronic lung disease other than asthma, which may impair lung function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 4,12, 24, 36, and 48 week
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will investigate if a certain gene variant will respond better to a 48 week therapy with dupilumab, in order to help manage asthma exacerbations.
Who is the study for?
This trial is for individuals aged 12 and older with asthma, who can perform lung function tests and have had an asthma attack in the past year. They must be on a stable dose of corticosteroids or have used biologic medication recently. Smokers or recent quitters, pregnant/breastfeeding women, those with other chronic lung diseases, or using certain drugs are excluded.
What is being tested?
The study examines if Dupilumab reduces asthma attacks over 48 weeks in patients carrying the IL-4RαR576 gene variant compared to a placebo. Participants' response to this anti-IL-4R therapy will be monitored by tracking exacerbation rates.
What are the potential side effects?
Dupilumab may cause injection site reactions, eye inflammation (conjunctivitis), oral herpes infections, and rare but serious allergic reactions. The side effects experienced can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and my pregnancy test is negative.
Select...
I've been on a stable, medium to high dose asthma medication for at least 3 months or used a biologic asthma medication in the last 8 weeks.
Select...
I had a severe asthma attack in the last year.
Select...
I am 12 years old or older.
Select...
I have been diagnosed with asthma by a doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't needed antibiotics or steroids for a lung problem in the last 4 weeks.
Select...
I have a long-term lung condition that is not asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average of 4,12, 24, 36, and 48 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 4,12, 24, 36, and 48 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The rate of asthma exacerbations
Secondary study objectives
Change in CASI score
Change in pre-bronchodilator lung function
Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: Treatment groupExperimental Treatment1 Intervention
Dupilumab (Dupixent®) administered subcutaneously every two weeks. An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week.
Group II: Placebo groupPlacebo Group1 Intervention
Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,616 Total Patients Enrolled
51 Trials studying Asthma
29,568 Patients Enrolled for Asthma
Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,581 Total Patients Enrolled
17 Trials studying Asthma
7,361 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,322 Previous Clinical Trials
5,364,588 Total Patients Enrolled
59 Trials studying Asthma
11,729 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on immunosuppressants for conditions other than asthma.You are currently smoking or quit smoking less than 6 months ago.You have used an electronic vaping device or quit using it less than 6 months before the screening.I haven't needed antibiotics or steroids for a lung problem in the last 4 weeks.I can do breathing tests.I am a woman who can have children and my pregnancy test is negative.I am on a stable allergen immunotherapy plan for at least 2 months.I am 12 years old or older.I have been diagnosed with asthma by a doctor.I agree to use approved birth control methods during the study.I've been on a stable, medium to high dose asthma medication for at least 3 months or used a biologic asthma medication in the last 8 weeks.I had a severe asthma attack in the last year.I have not received a live vaccine in the last 4 weeks.You have had problems with drinking too much alcohol or using illegal drugs in the last 6 months.Your blood test shows very low levels of white blood cells, platelets, or hemoglobin, or high levels of eosinophils.I have a long-term lung condition that is not asthma.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: Treatment group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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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