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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 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 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

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

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Dupilumab/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/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

0 / 7Eligibility criteria met