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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

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 below
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I am a woman who can have children and my pregnancy test is negative.
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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.
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I had a severe asthma attack in the last year.
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I am 12 years old or older.
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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:
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I haven't needed antibiotics or steroids for a lung problem in the last 4 weeks.
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I have a long-term lung condition that is not asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 4,12, 24, 36, and 48 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 4,12, 24, 36, and 48 week for reporting.

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 • NCT04033367
9%
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

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
2,189 Previous Clinical Trials
4,033,091 Total Patients Enrolled
49 Trials studying Asthma
27,493 Patients Enrolled for Asthma
Boston Children's HospitalLead Sponsor
780 Previous Clinical Trials
5,580,906 Total Patients Enrolled
17 Trials studying Asthma
7,361 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,311 Previous Clinical Trials
5,626,524 Total Patients Enrolled
59 Trials studying Asthma
11,735 Patients Enrolled for Asthma

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03694158 — Phase 4
Asthma Research Study Groups: Placebo group, Treatment group
Asthma Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT03694158 — Phase 4
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03694158 — Phase 4
~56 spots leftby Sep 2026
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