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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 belowSelect...
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:Select...
I have a chronic lung condition other than asthma.
Select...
I have an active autoimmune disease or am on immunosuppressive therapy for one.
Select...
I am not on any treatments that are not allowed in the study.
Select...
I plan to get live vaccines during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 2, 4, 8, 12, 24, 36, 52, and 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2, 4, 8, 12, 24, 36, 52, and 64
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 moreAwards & 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
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Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
664 Previous Clinical Trials
385,576 Total Patients Enrolled
29 Trials studying Asthma
11,345 Patients Enrolled for Asthma
SanofiLead Sponsor
2,197 Previous Clinical Trials
4,034,491 Total Patients Enrolled
50 Trials studying Asthma
28,353 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,019,996 Total Patients Enrolled
19 Trials studying Asthma
8,898 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child aged 6-11 with asthma diagnosed by a doctor for over a year.You had a bad reaction to dupilumab in the past, and your doctor thinks it's not safe for you to take it again.People from Brazil who stopped taking the study medication early to get the Yellow Fever vaccine during a Yellow Fever outbreak can join the study after finishing all the required procedures from the previous study.I have a chronic lung condition other than asthma.My child has asthma and finished a dupilumab trial.You have an untreated parasitic infection or are at high risk for getting one, unless the doctor has confirmed that you don't have an active infection.I have an active autoimmune disease or am on immunosuppressive therapy for one.I have been treated with dupilumab in Japan.I am not on any treatments that are not allowed in the study.In the Japan sub-study, you have a high level of blood eosinophils or fractional exhaled nitric oxide during the screening visit.I am a menstruating woman not using birth control or might be pregnant.I plan to get live vaccines during the study.You have a history of weakened immune system or frequent, serious infections, even if they have been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
Awards:
This trial has 2 awards, including:- 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.
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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