Dupilumab for Childhood Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
Primary Objective:* To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.* To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study.Secondary Objectives:* To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.* To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: * Systemic exposure. * Anti-drug antibodies (ADAs). * Biomarkers.* To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study* To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers
Who Is on the Research Team?
Clinical Sciences & Operations
Principal Investigator
Sanofi
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive doses of dupilumab every 2 or 4 weeks added to current controller medications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School