Dupilumab for Asthma

(IDEA Trial)

Recruiting at 7 trial locations

Overseen By Research Manager

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Children's Hospital

Must be taking: Inhaled corticosteroids, Biologics

Must not be taking: Immunosuppressives, Immunomodulators

Disqualifiers: Chronic lung disease, Smoking, Pregnancy, others

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: 48 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dupilumab (also known as Dupixent) can reduce asthma attacks in people with a specific gene variant. Participants will receive either dupilumab or a placebo (a substance with no active medication) every two weeks for 48 weeks. The trial seeks individuals 12 years and older who have asthma, use inhalers regularly, and have experienced a severe asthma attack in the past year. As a Phase 4 trial, this research helps to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, if you are on allergen immunotherapy, you must continue it for the duration of the study.

What is the safety track record for dupilumab?

Research has shown that patients generally tolerate dupilumab well. In previous studies, some participants experienced more colds and mild injection site reactions compared to those who received a placebo. These were the most common side effects and are usually easy to manage.

The FDA has already approved dupilumab for other conditions like eczema and chronic sinus issues, so its safety profile is well-established. While some side effects exist, many patients respond well to the treatment. For those with asthma considering joining a trial, this information may help in understanding the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets the underlying inflammation associated with asthma by inhibiting the signaling of interleukins IL-4 and IL-13, which are key drivers of allergic inflammation. Unlike standard treatments like inhaled corticosteroids or bronchodilators that primarily manage symptoms, Dupilumab addresses the root cause of inflammation. Researchers are excited about this treatment because it offers a new mechanism of action that could lead to better control of asthma symptoms and potentially improve the quality of life for patients with difficult-to-treat asthma. Additionally, Dupilumab is administered via a convenient subcutaneous injection every two weeks, which may offer more consistent relief compared to daily medications.

What is the effectiveness track record for dupilumab in treating asthma?

Studies have shown that dupilumab effectively treats moderate-to-severe asthma. In this trial, participants in the treatment group will receive dupilumab, which has resulted in fewer asthma attacks compared to a placebo. Dupilumab blocks certain proteins that cause airway swelling, helping to reduce asthma symptoms. Research also shows that it can improve breathing and reduce the need for oral steroids. Researchers are now studying this treatment further to determine its effectiveness in people with a specific gene variant. Overall, dupilumab effectively manages asthma symptoms and has been well-received. ^{1 2 3 6 7}

Who Is on the Research Team?

Wanda Phipatanakul, MD, MS

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 and older with asthma, who can perform lung function tests and have had an asthma attack in the past year. They must be on a stable dose of corticosteroids or have used biologic medication recently. Smokers or recent quitters, pregnant/breastfeeding women, those with other chronic lung diseases, or using certain drugs are excluded.

Inclusion Criteria

Ability to provide informed consent

I can do breathing tests.

I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures

I am not currently on immunosuppressants for conditions other than asthma.

You have used an electronic vaping device or quit using it less than 6 months before the screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-12 weeks

Run-in

Run-in period to determine asthma control before randomization

2-12 weeks

Treatment

Participants receive subcutaneous Dupilumab or placebo every two weeks for 48 weeks

48 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The study examines if Dupilumab reduces asthma attacks over 48 weeks in patients carrying the IL-4RαR576 gene variant compared to a placebo. Participants' response to this anti-IL-4R therapy will be monitored by tracking exacerbation rates.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

Dupilumab (Dupixent®) administered subcutaneously every two weeks. An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week.

Group II: Placebo group Placebo Group 1 Intervention

Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two 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?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Sanofi

Industry 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

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

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

HealthBeacon Plc

Industry Sponsor

Trials

2

Recruited

160+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

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 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]

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 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]

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, 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]

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]

Citations

1. 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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1304048

Dupilumab in Persistent Asthma with Elevated Eosinophil ... The objective of this study was to assess the efficacy and safety of dupilumab in adults with persistent, moderate-to-severe asthma and elevated eosinophil ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Study of Dupilumab (REGN668/​SAR231893) ... Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis.

4. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-announce-publication-positive-phase-2a

Sanofi and Regeneron Announce Publication of Positive ... The New England Journal of Medicine published online the positive Phase 2a study results of dupilumab ( SAR231893 /REGN668) in patients with moderate-to-severe ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02414854

Study Details | NCT02414854 | Evaluation of Dupilumab in ... A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596600/

Clinical Review - Dupilumab (Dupixent) - NCBI Bookshelf - NIH The primary outcome was the annualized rate of severe exacerbations, while the key secondary outcome was pulmonary function measurement (i.e., change from ...

7. 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 ...