Dupilumab + ICS/LABA for Asthma

(AIM4:Next Step Trial)

Recruiting at 97 trial locations

Overseen By Clinical Trials Administrator

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Regeneron Pharmaceuticals

Must be taking: ICS/LABA

Must not be taking: Systemic corticosteroids

Disqualifiers: COPD, Lung diseases, Smoking, 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: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the drug dupilumab (also known as Dupixent) for individuals with uncontrolled asthma. The aim is to determine if adding dupilumab to an inhaled asthma medication is more effective than simply increasing the dose of the inhaled medication. The inhaled medication combines corticosteroids and long-acting beta-agonists (ICS/LABA), and some participants may also use a long-acting muscarinic antagonist (LAMA). The study also monitors any side effects from dupilumab. Individuals who have had asthma for over a year and continue to experience frequent symptoms despite current treatment may be suitable candidates for this trial. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that you continue using your current inhaled asthma medication (ICS/LABA) and possibly a LAMA if you are already on it. You cannot be on systemic corticosteroids from one month before the trial starts.

What is the safety track record for dupilumab?

Studies have shown that dupilumab is generally well-tolerated by patients. Research indicates that while some people experience side effects like colds and injection site reactions, these do not occur in everyone. Dupilumab has also been shown to reduce asthma attacks and improve breathing in people with moderate to severe asthma. Participants should know that the FDA has already approved dupilumab for asthma, which adds confidence to its safety. Those considering joining a trial should discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets and blocks the action of a specific protein involved in inflammation called IL-4, which plays a key role in asthma. Unlike traditional treatments for asthma, which typically include inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) to manage symptoms, Dupilumab offers a new mechanism by directly addressing the underlying inflammation. Researchers are excited about Dupilumab because it could provide more effective control of asthma symptoms and reduce reliance on steroids, which can have significant side effects over long-term use.

What evidence suggests that this trial's treatments could be effective for uncontrolled asthma?

Studies have shown that dupilumab effectively treats asthma, particularly in moderate to severe cases. In this trial, participants will receive either dupilumab or a placebo, both alongside standard asthma medications (ICS/LABA). Research indicates that patients taking dupilumab experienced fewer severe asthma attacks and better overall asthma control. Specifically, they had fewer symptomatic days and could breathe more easily. Dupilumab also reduced a marker of inflammation in the body called FeNO. These findings suggest that combining dupilumab with standard asthma medications can significantly enhance asthma management. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adolescents and adults who have had asthma for at least a year, are currently on medium dose ICS/LABA, and still experience frequent symptoms. They should have had at least one severe asthma attack in the past year but not within the last 30 days. Participants must also meet certain lung function criteria and blood eosinophil levels.

Inclusion Criteria

I use up to 3 medications to control my asthma.

I have been diagnosed with asthma for at least a year.

My lung function improves significantly after using an inhaler or has a history of major decrease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Dupilumab with ICS/LABA or a higher dose of ICS/LABA for asthma management

12 weeks

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 compares two treatments: adding dupilumab to an existing medium dose of ICS/LABA versus increasing the ICS/LABA dosage alone. The goal is to determine which approach better controls asthma symptoms.

How Is the Trial Designed?

Group I: Dupilumab + ICS/LABA Experimental Treatment 2 Interventions

Randomized 1:1

Group II: Placebo + ICS/LABA Placebo Group 2 Interventions

Randomized 1:1

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?

Regeneron Pharmaceuticals

Lead 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

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

Published Research Related to This Trial

In a study of 18 severe asthma patients treated with dupilumab for 12 months, significant improvements were observed in asthma control, with the Asthma Control Test (ACT) score increasing from 15.7 to 22.4, and a complete cessation of oral corticosteroid use in all patients.

Dupilumab treatment also led to a notable reduction in asthma exacerbations from an average of 2 to 0, and an increase in lung function (FEV1%) from 73.5% to 87.1%, confirming its effectiveness in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience with Dupilumab in Severe Asthma: One-Year Data from an Italian Named Patient Program. Campisi, R., Crimi, C., Nolasco, S., et al.[2022]

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]

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 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 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 is a monoclonal antibody that targets the IL-4 receptor, effectively reducing severe asthma exacerbations and improving lung function in patients aged 12 and older with moderate-to-severe asthma, based on three pivotal trials lasting 24-52 weeks.

The treatment is generally well tolerated and allows for a reduction in oral corticosteroid doses without compromising asthma control, particularly benefiting patients with higher levels of type 2 inflammation, such as those with elevated eosinophils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate to Severe Asthma. Deeks, ED.[2020]

In a study of 2400 asthma patients aged 12 and older, dupilumab significantly reduced the risk of asthma exacerbations by 44% and systemic corticosteroid prescriptions by 48% after initiation, indicating its strong effectiveness in real-world settings.

The effectiveness of dupilumab was consistent regardless of patients' previous exacerbation history, eosinophil levels, or the impact of COVID-19, suggesting it is a reliable treatment option for managing moderate-to-severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of dupilumab in patients with asthma: Findings from the US ADVANTAGE study. Blaiss, M., Bleecker, ER., Jacob-Nara, J., et al.[2023]

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

Patient outcomes and safety of combination biologic ... Phase 2 trial: Itepekimab improved asthma outcomes; combination with dupilumab offered no added benefit. Low. eTable 2. Summary of Literature. Abbreviations ...

5. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/pa5371

Dupilumab Reduces Exacerbations and FeNO Levels and ... Dupilumab significantly reduced severe exacerbation rates over the treatment period and sustainably improved asthma control and reduced FeNO levels.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668 ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with ...

7. dupixenthcp.com dupixenthcp.com/asthma/efficacy

Efficacy and Safety Overview DUPIXENT reduced severe exacerbations, improved lung function, reduced or eliminated OCS use, and has a demonstrated safety profile.

8. 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 ...