Dupilumab for Childhood Asthma

Recruiting at 230 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Immunosuppressants

Disqualifiers: Chronic lung disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

365 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-5 weeks

Treatment

Participants receive doses of dupilumab every 2 or 4 weeks added to current controller medications

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Dupilumab

Trial Overview 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.

Participant Groups

Group I: Dupilumab Experimental Treatment 3 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:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

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