Dupilumab for Childhood Asthma

Recruiting in Palo Alto (17 mi)

+149 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

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

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

Signed written informed consent/assent

I am a child aged 6-11 with asthma diagnosed by a doctor for over a year.

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.

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Exclusion Criteria

Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders)

You had a bad reaction to dupilumab in the past, and your doctor thinks it's not safe for you to take it again.

Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient's participation in this study or would require permanent IMP discontinuation

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Treatment Details

Interventions

Dupilumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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

Dupilumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Dupixent for: