Dupilumab for Asthma

(ATLAS Trial)

Recruiting at 647 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sanofi

Must be taking: Inhaled corticosteroids, LABA

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: COPD, Active infection, Cancer, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

1324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug dupilumab (also known as Dupixent) can slow or prevent lung function decline in individuals with moderate to severe asthma that isn't well-controlled. Participants will receive either dupilumab or a placebo to compare its effects against standard asthma treatments over three years. Those who have had asthma for at least a year and are using high-dose inhalers with other asthma medications might be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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

The trial does not specify that you need to stop your current asthma medications. In fact, it requires that you continue your current asthma treatments at a stable dose for at least one month before joining. However, if you are on any biologic therapies, you must stop them at least 4 weeks before the trial.

What is the safety track record for these treatments?

Research has shown that dupilumab is generally safe for people with asthma. In one study, only 6% of patients using dupilumab experienced an asthma attack, compared to 44% of those who took a placebo, indicating an 87% reduction in asthma attacks. Another study found that dupilumab is safe for use up to three years, with no new safety concerns.

Both adults and children have safely used dupilumab for at least a year. Reports indicate that its safety after one year is similar to that observed after six months. Overall, dupilumab has a strong safety record and is FDA-approved for asthma and other conditions, providing extra reassurance about its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, Dupilumab is unique because it targets a specific part of the immune system. It works by blocking interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key drivers of inflammation in asthma. This targeted approach can offer relief to patients who do not respond well to traditional therapies. Researchers are excited about Dupilumab because it has the potential to reduce asthma attacks and improve lung function more effectively in certain patients.

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

Research has shown that dupilumab, which participants in this trial may receive, effectively treats moderate to severe asthma. Studies have found that it reduces asthma attacks and improves lung function. For example, patients taking dupilumab experienced fewer severe asthma flare-ups (sudden worsening of symptoms) compared to those taking a placebo, the comparator in this trial. Additionally, dupilumab improved lung function, aiding in breathing. These findings suggest that dupilumab can benefit people with uncontrolled asthma. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with uncontrolled moderate to severe asthma who have had a recent asthma attack requiring steroids or an ER visit, poor lung function (FEV1 ≤ 80%), and not well controlled on current meds. Must be non-smokers for at least 6 months and without other significant health issues like active infections, cancer in the past 5 years, or immune system problems.

Inclusion Criteria

I have had one or more severe flare-ups in the past year.

My lung function improved significantly after using a quick-relief inhaler.

I am at least 18 years old or the legal age of consent where the study is conducted.

Exclusion Criteria

I might have a parasite infection or have taken antiparasitic drugs recently.

I have not received a live vaccine within the last 4 weeks.

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4±1 weeks

Treatment

Participants receive dupilumab or placebo every 2 weeks for 3 years to assess the effect on lung function decline

3 years

Bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Placebo

Trial Overview

The trial is testing Dupilumab against a placebo to see if it can slow down worsening of lung function in adults with serious asthma. Participants will either get Dupilumab or a fake drug (placebo) alongside their regular treatments for three years, without knowing which one they're getting.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 1 Intervention

Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1

Group II: Placebo Placebo Group 1 Intervention

Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 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?

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

In a study of 64 patients with severe asthma, dupilumab significantly improved asthma control and lung function after 12 months, as evidenced by a notable increase in asthma control test scores and forced expiratory volume.

Dupilumab also reduced the need for oral steroids and the frequency of asthma exacerbations, although some patients experienced hypereosinophilia, which did not affect the overall clinical response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. Dupin, C., Belhadi, D., Guilleminault, L., et al.[2021]

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 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]

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 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]

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 ...

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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.

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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.

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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 ...

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dupixenthcp.com

dupixenthcp.com/asthma/efficacy/safety-data

Safety Data For Asthma | DUPIXENT® (dupilumab)

Explore safety data across clinical trials in patients aged 12+ with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral ...

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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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38163585/

Long-Term Safety of Dupilumab in Patients With Moderate- ...

Conclusions: Dupilumab treatment was well tolerated for up to an additional 3 years. Safety findings were consistent with the known safety profile of dupilumab.

9.

dupixent.com

dupixent.com/asthma/about-dupixent/results-with-dupixent

DUPIXENT® (dupilumab) Results in Asthma (12+ years)

For both adults and children, the safety profile of DUPIXENT through Week 52 was generally consistent with the safety profile observed at Week 24.