Dupilumab + ICS/LABA for Asthma

(AIM4:Next Step Trial)

Recruiting at 80 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

Trial Summary

What is the purpose of this trial?

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab

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 data supports the effectiveness of the drug Dupilumab for asthma?

Dupilumab has been shown to reduce severe asthma attacks, improve lung function, and enhance asthma control in patients with moderate-to-severe asthma, especially those with type 2 inflammation. It is generally well tolerated and can help reduce the need for oral corticosteroids without worsening asthma control. ^{1 2 3 4 5}

Is Dupilumab safe for treating asthma?

Dupilumab, used for asthma and other conditions, is generally considered safe with minimal side effects. However, it may cause an increase in blood eosinophils (a type of white blood cell) and has been associated with some eye-related side effects, mainly in patients treated for skin conditions. ^{1 2 3 6 7}

How is the drug Dupilumab different from other asthma treatments?

Dupilumab is unique because it targets the IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation in asthma, and it can be effective for both eosinophilic and non-eosinophilic severe asthma. Unlike some other treatments, it is administered as a subcutaneous injection every two weeks and has shown benefits in reducing severe asthma attacks and improving lung function. ^{1 2 3 4 8}

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

Key

I use up to 3 medications to control my asthma.

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of asthma. [2019]

3. Italy 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. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Real-World Experience with Dupilumab in Severe Asthma: One-Year Data from an Italian Named Patient Program. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of dupilumab in patients with asthma: Findings from the US ADVANTAGE study. [2023]