Dupilumab for Asthma

Recruiting at 130 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Inhaled corticosteroids

Must not be taking: Oral corticosteroids

Disqualifiers: Severe asthma, Anaphylaxis, Prematurity, others

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

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called dupilumab (also known as Dupixent) to determine its effectiveness for young children aged 2 to under 6 with uncontrolled asthma or frequent severe wheezing. The trial aims to assess the safety and effectiveness of this treatment over an extended period. The study consists of two parts: an initial year comparing dupilumab with a placebo (an inactive substance), followed by an optional additional year where all participants receive dupilumab. Children whose asthma is not well-managed with their usual medication and who experience frequent severe wheezing may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in asthma treatment.

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

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have been using a stable dose of inhaled corticosteroids (ICS) for at least one month before the screening, which suggests you may need to continue your current asthma medication.

Is there any evidence suggesting that dupilumab is likely to be safe for children with asthma?

Research has shown that dupilumab is generally safe for patients. In earlier studies, some participants experienced side effects such as colds and injection site reactions. However, these side effects were not serious for most individuals. Overall, the treatment has shown promise in alleviating asthma symptoms. While no treatment is without risk, extensive studies have deemed dupilumab's safety acceptable for many patients. It is important to discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

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

Researchers are excited about dupilumab for asthma because it targets a specific pathway involved in the inflammation process. Current asthma treatments, like inhaled corticosteroids and bronchodilators, primarily focus on reducing symptoms and preventing attacks. Dupilumab, however, works by blocking the signaling of interleukin-4 and interleukin-13, proteins that play a key role in allergic inflammation. This targeted approach could offer improved control for asthma patients whose symptoms aren't well-managed by existing treatments. Additionally, since it's administered through subcutaneous injection, it could provide a convenient option for those looking for alternatives to daily inhalers.

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

Research has shown that dupilumab, which participants in this trial may receive, helps reduce asthma symptoms. Studies indicate it can lower the risk of asthma attacks by 44% and greatly decrease the need for oral corticosteroids, strong anti-inflammatory medicines. In another study, dupilumab led to an 87% drop in asthma flare-ups compared to a placebo. Additionally, 75% of patients using dupilumab showed improved asthma control scores. These findings suggest that dupilumab could be a promising treatment for managing uncontrolled asthma in young children. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 2 to less than 6 with uncontrolled asthma or severe asthmatic wheeze, diagnosed with Atopic Dermatitis. They must have been on inhaled corticosteroids for at least a month and show allergic reactions to certain foods or airborne allergens. Parents need to understand study requirements and help their kids follow the protocol.

Inclusion Criteria

Parents or guardians are able to bring the child to all clinic visits and follow study instructions.

The parent(s) or guardian(s) should be able to understand what is needed for the study.

Participants/parent(s)/caregiver(s)/legal guardian(s) must be able to understand and complete study-related questionnaires

Exclusion Criteria

I have had severe asthma attacks that were life-threatening.

History of a systemic hypersensitivity reaction or anaphylaxis to dupilumab or any other biologic therapy

I have severe asthma and need to take steroids regularly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either dupilumab or placebo for 52 weeks in a double-blind manner

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with dupilumab for an additional 52 weeks

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview

The study tests Dupilumab's effectiveness and safety against a placebo over a year (Part A), followed by an optional second year (Part B). It's double-blind, meaning neither participants nor researchers know who gets the real drug during Part A.

How Is the Trial Designed?

Group I: Dupilumab (double-blind period) Experimental Treatment 1 Intervention

Dupilumab subcutaneous injection as per protocol

Group II: Placebo Placebo Group 1 Intervention

Placebo matching dupilumab subcutaneous injection as per protocol

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

Published Research Related to This Trial

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, blocking signals from IL-4 and IL-13, and is currently in phase III trials for treating moderate-to-severe asthma, showing promise for both eosinophilic and non-eosinophilic asthma phenotypes.

While dupilumab appears to be generally well tolerated, further large-scale studies are necessary to fully evaluate its long-term safety and efficacy, especially in pediatric populations where data is currently lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of asthma. Santini, G., Mores, N., Malerba, M., et al.[2019]

In a real-life study of 12 patients with severe type-2 asthma, dupilumab treatment for 3 months led to significant improvements in asthma control (ACT score) and lung function (FEV1), indicating its efficacy in managing symptoms.

The treatment also resulted in a notable reduction in FeNO levels, a biomarker for type-2 inflammation, although blood eosinophil counts did not show significant change, suggesting that dupilumab effectively targets the IL4/IL13 pathway in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. Carpagnano, GE., Scioscia, G., Buonamico, E., et al.[2022]

In a study of 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume and asthma control questionnaire scores over 12 and 24 weeks in 13 trials.

The treatment is generally safe, showing no significant increase in adverse events compared to placebo, although it was associated with higher blood eosinophil levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. Zaazouee, MS., Alwarraqi, AG., Mohammed, YA., et al.[2022]

Dupilumab, a monoclonal antibody that blocks IL-4 and IL-13 signaling, has been shown to significantly improve asthma symptoms and reduce exacerbation rates in adolescents and adults, based on Phase II and III clinical trials.

The treatment has a favorable safety profile and has also been approved for use in atopic dermatitis, highlighting its effectiveness across multiple atopic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in the treatment of asthma. Grey, A., Katelaris, CH.[2020]

In a study of 99 patients with severe asthma, the majority exhibited diverse clinical characteristics, with 58% having adult-onset asthma and 48% showing an allergic phenotype, indicating a range of profiles among those eligible for dupilumab treatment.

The analysis revealed that 70% of patients met at least one GINA criterion for type 2 airway inflammation, and 64% had comorbidities associated with type 2 inflammation, highlighting the complexity of managing severe asthma in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study. Korn, S., Schmidt, O., Timmermann, H., et al.[2023]

Dupilumab significantly improved the quality of life for adolescents with uncontrolled severe asthma within just 4 weeks of treatment, with 80% of participants able to reduce their inhaled corticosteroid dosage.

Throughout the 24-week study, none of the five adolescents experienced asthma exacerbations, indicating that dupilumab effectively controlled their asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. Indolfi, C., Dinardo, G., Klain, A., et al.[2023]

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37967668/

Real-world effectiveness of dupilumab in patients with ...

After initiation of dupilumab, risk of asthma exacerbation was reduced by 44% (IRR, 0.56; 95% CI, 0.47-0.57; P = <0.0001) and systemic corticosteroid ...

2.

dupixenthcp.com

dupixenthcp.com/asthma/efficacy

Efficacy and Safety Overview

75% of patients had improved ACQ-5 (asthma control) scores with DUPIXENT 200 mg Q2W + SOC vs 67% with placebo + SOC (OR: 1.46 [95% CI: 0.90, 2.35]) (baseline ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1304048

Dupilumab in Persistent Asthma with Elevated Eosinophil ...

Three patients had an asthma exacerbation with dupilumab (6%) versus 23 with placebo (44%), corresponding to an 87% reduction with dupilumab ( ...

4.

newsroom.regeneron.com

newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-presented-ats-reinforce-impact

Dupixent® (dupilumab) Data Presented at ATS Reinforce ...

... Dupixent reduced exacerbations and improved disease control regardless of how long they had the disease. The safety results in the asthma trials were ...

5.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1631321/full

Exploring dupilumab for asthma: from mechanistic insights ...

Overall, this reviewed trial demonstrated that dupilumab can significantly reduce or eliminate chronic OCS intake while improving asthma outcomes in severe ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9574251/

Dupilumab efficacy and safety in patients with moderate to ...

Compared to the placebo, dupilumab revealed a significantly higher incidence of upper respiratory tract infections (URTI), injection-site reaction, and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ...

The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic ... Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe ...

8.

annallergy.org

annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ...

Combination biologic therapy with dupilumab is well-tolerated in select patients, suggesting promising efficacy in addressing comorbid conditions, refractory ...

9.

investor.regeneron.com

investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data

Sanofi and Regeneron Report Positive Proof-of-Concept ...

Treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms ...