Dupilumab for Childhood Asthma

No longer recruiting at 257 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of dupilumab, a monoclonal antibody, for children with asthma who participated in a previous study. The main goal is to evaluate the treatment's long-term effectiveness and potential side effects. The trial focuses on children in Japan with uncontrolled asthma that hasn't improved with treatment. Children who have had asthma for over a year and participated in an earlier dupilumab trial might qualify if their asthma remains poorly controlled. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking asthma treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not clearly specify if you need to stop your current medications. However, it mentions that patients receiving treatments prohibited in the study cannot participate, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that dupilumab is generally safe for children aged 6 to 11 years with moderate-to-severe asthma. Studies have found that it greatly reduces severe asthma attacks and improves breathing in these children. Common side effects include injection site reactions, sore throat, and eye issues, but these are usually mild. The FDA has already approved dupilumab for other conditions, supporting its safety. Overall, the safety information appears promising for children with asthma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Dupilumab is unique because it targets a specific pathway involving the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, which play a significant role in the inflammatory process of asthma. Unlike standard treatments like inhaled corticosteroids or leukotriene modifiers that broadly reduce inflammation, dupilumab specifically blocks these proteins, potentially leading to more precise control of asthma symptoms. Researchers are excited about this treatment because it offers a new mechanism of action that may benefit children who don't respond well to existing therapies, providing an option that could better manage their condition with less frequent dosing.

What evidence suggests that dupilumab might be an effective treatment for childhood asthma?

Research has shown that dupilumab, which participants in this trial will receive, helps treat asthma in children. Studies found it significantly reduces severe asthma attacks and improves breathing in kids with moderate to severe asthma. Specifically, dupilumab reduced the rate of severe attacks by 59-63% in children. Additionally, children began breathing better within just two weeks of treatment. These results suggest that dupilumab could be a promising option for managing asthma in children. ^{1 3 4 6 7}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39613097/

Dupilumab Efficacy and Safety in Children With Moderate ... Dupilumab significantly reduced severe exacerbations and improved lung function in children with moderate-to-severe asthma and baseline blood eosinophil counts.

2. dupixent.com dupixent.com/asthma/about-dupixent/results-in-children

Results in Children (6-11 Years) The Results Show How DUPIXENT Helped · Better breathing in children in as little as 2 weeks · Significantly fewer asthma attacks · Substantial reduction in steroid ...

3. aaaai.org aaaai.org/tools-for-the-public/latest-research-summaries/the-journal-of-allergy-and-clinical-immunology-in/2024/pediatric

Dupilumab treatment improves pediatric asthma outcomes Through this analysis, the investigators found that across both ICS-dose groups, dupilumab reduced severe exacerbation rates by 59–63% and ...

4. dupixenthcp.com dupixenthcp.com/asthma/efficacy

Efficacy and Safety Overview Adults and Pediatric Patients (12+ Years)​​ 75% of patients had improved ACQ-5 (asthma control) scores with DUPIXENT 200 mg Q2W + SOC vs 67% with placebo + SOC ( ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2106567

Dupilumab in Children with Uncontrolled Moderate-to- ... Among children with uncontrolled moderate-to-severe asthma, those who received add-on dupilumab had fewer asthma exacerbations and better lung function and ...

6. dupixenthcp.com dupixenthcp.com/asthma/efficacy/children-safety-data

safety data in children (6-11 years) Find the safety profile, including common side effects, of DUPIXENT® (dupilumab) in pediatric patients aged 6-11 years with moderate-to-severe asthma ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213219824011796

Dupilumab Efficacy and Safety in Children With Moderate ... Dupilumab significantly reduced severe exacerbations and improved lung function in children with moderate-to-severe asthma and baseline blood eosinophil counts.