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Monoclonal Antibodies

Dupilumab for Childhood Asthma

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Japan sub-study: Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to screening
Be younger than 18 years old
Must not have
Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function
Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 2, 4, 8, 12, 24, 36, 52, and 64
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is looking at the long-term safety and efficacy of dupilumab in children with asthma. They will also be looking at the exposure to the drug, any adverse reactions, and any biomarkers associated with the drug.

Who is the study for?
This trial is for children who have asthma and were part of a previous dupilumab study. They must have completed their treatment, given consent, and meet specific criteria like blood eosinophil count or FeNO levels. It's not open to those with certain relationships to the study team, language barriers, psychological disorders, prohibited treatments, hypersensitivity to dupilumab, other lung diseases besides asthma, autoimmune diseases requiring immunosuppression therapy or live vaccinations planned during the study.
What is being tested?
The trial tests the long-term safety and effectiveness of dupilumab in pediatric patients with uncontrolled persistent asthma. It includes monitoring drug exposure in the body, immune responses against the drug (ADAs), and various biomarkers related to asthma. The Japan sub-study focuses on children aged 6-11 with additional eligibility requirements.
What are the potential side effects?
Possible side effects include allergic reactions at injection sites such as redness or swelling; common cold symptoms; headache; sore throat; eye inflammation; stomach pain; potential increase in white blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a child aged 6-11 with asthma diagnosed by a doctor for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a chronic lung condition other than asthma.
Select...
I have an active autoimmune disease or am on immunosuppressive therapy for one.
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I am not on any treatments that are not allowed in the study.
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I plan to get live vaccines during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2, 4, 8, 12, 24, 36, 52, and 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2, 4, 8, 12, 24, 36, 52, and 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Japan sub-study: Change from baseline in pre-bronchodilator percentage (%) predicted FEV1 at Week 12
The number of patients experiencing any treatment emergent adverse event (TEAE)
Secondary study objectives
Annualized rate of severe asthma exacerbation events during the treatment period
Blood eosinophil counts
Change from baseline in % predicted FEV1
+17 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment3 Interventions
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,459 Total Patients Enrolled
29 Trials studying Asthma
11,345 Patients Enrolled for Asthma
SanofiLead Sponsor
2,216 Previous Clinical Trials
4,047,267 Total Patients Enrolled
51 Trials studying Asthma
29,315 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,022,451 Total Patients Enrolled
19 Trials studying Asthma
8,860 Patients Enrolled for Asthma

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03560466 — Phase 3
Asthma Research Study Groups: Dupilumab
Asthma Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT03560466 — Phase 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03560466 — Phase 3
~14 spots leftby Mar 2025
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