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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
Ability to perform pulmonary function tests
Female participants of childbearing potential must have a negative urine pregnancy test upon study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 4,12, 24, 36, and 48 week
Awards & highlights

IDEA 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.Check my eligibility
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.See study design
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.

IDEA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do breathing tests.
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I am a woman who can have children and my pregnancy test is negative.
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I agree to use approved birth control methods during the study.
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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.

IDEA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of asthma exacerbations
Secondary outcome measures
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: Dupilumab
DB Period: Placebo
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

IDEA 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
~12230

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor
2,160 Previous Clinical Trials
3,514,312 Total Patients Enrolled
46 Trials studying Asthma
27,188 Patients Enrolled for Asthma
Boston Children's HospitalLead Sponsor
758 Previous Clinical Trials
5,579,160 Total Patients Enrolled
17 Trials studying Asthma
7,631 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,265 Previous Clinical Trials
5,483,902 Total Patients Enrolled
58 Trials studying Asthma
11,385 Patients Enrolled for Asthma

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03694158 — Phase 4
Asthma Research Study Groups: Treatment group, Placebo 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential participants in this trial?

"Affirmative. Clinicaltrials.gov displays that this research project, which was originally unveiled on September 8th 2021 is still open to volunteers. It seeks to enrol 150 people across 7 separate medical facilities."

Answered by AI

How many participants are currently taking part in this experiment?

"Correct. According to clinicaltrials.gov, this medical study is actively seeking participants that meet the criteria for inclusion. It was opened on September 8th 2021 and last updated on August 8th 2022; 150 subjects need to be enrolled at 7 distinct locations."

Answered by AI

Does this experiment represent an unprecedented approach to treatment?

"To date, Dupilumab has been studied in 49 separate trials hosted over 436 cities and 43 countries. The first clinical trial occurred back in 2015, sponsored by Sanofi with 880 participants who completed Phase 3 regulatory review. Since then, 18360 additional studies have taken place."

Answered by AI

What potential harm could be caused by using Dupilumab?

"The safety rating for Dupilumab is a 3, as this product has been approved following four phases of clinical trials."

Answered by AI

What medical conditions is Dupilumab commonly utilized to treat?

"Dupilimab is the primary remedy for treating atopic dermatitis. It can also help people whose corticosteroid therapy has failed as well as those suffering from asthma and eosinophilic inflammation."

Answered by AI

What have been some of the previous explorations into Dupilumab's effectiveness?

"At present, 49 clinical trials aim to evaluate the efficacy of Dupilumab. Of those studies 13 are in Phase 3. While many research sites for this treatment can be found near Palo Alto, CA; a total of 2602 locations throughout America provide access to these tests and treatments."

Answered by AI

How many different sites are managing this research project?

"Participants for this medical study are being selected from MetroHealth System in Cleveland, Ohio; University of Pennsylvania in Philadelphia, Pennsylvania; Montefiore Einstein Clinical Research Center in Bronx, New york and 7 other sites."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

After having COVID for the fourth time, and pneumonia for the second time (in Nov./Dec. 2023), I my fatigue and asthma symptoms have intensified. I have tried a few different inhalers, as well as been on oral steroids, but have not improved.
PatientReceived 2+ prior treatments
~74 spots leftby Sep 2026