Dupilumab for Asthma

(VIA Trial)

Overseen By Deborah Murphy, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Virginia

Must be taking: Albuterol, Inhaled corticosteroids

Must not be taking: Asthma biologics, Antivirals

Disqualifiers: Smoking, COPD, 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: 2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dupilumab can prevent worsening asthma symptoms when individuals with mild to moderate asthma catch the common cold. Dupilumab, already approved for moderate to severe asthma, blocks inflammation pathways in the lungs. Participants will receive either dupilumab or a placebo (a harmless look-alike treatment) and then be exposed to a safe version of the cold virus. The study seeks individuals who have had asthma for at least six months, with symptoms well-controlled by typical asthma medications like albuterol. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used asthma biologic therapy, antiviral, immunosuppressive, or immune modulator therapies in the last 3 months. It also excludes those using inhaled nasal sprays.

What is the safety track record for this treatment?

Research shows that dupilumab, the treatment under study, is generally safe for people with asthma. In various studies, many patients with moderate to severe asthma have used dupilumab without major issues. Some individuals experienced mild side effects, such as colds or reactions at the injection site. Notably, the FDA has already approved dupilumab for treating asthma, which supports its safety profile. While some mild side effects were reported, they were not serious for most users. This suggests that dupilumab is relatively safe for people with asthma, though, like any treatment, some side effects might occur. ^{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 works by targeting a specific part of the immune system. It blocks the IL-4 and IL-13 signaling pathways, which are key players in the inflammation process that causes asthma symptoms. This unique mechanism of action offers hope for better control of asthma, especially for those who don't respond well to traditional therapies. Researchers are excited about Dupilumab because it addresses the root cause of inflammation rather than just alleviating symptoms.

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

Studies have shown that dupilumab, which participants in this trial may receive, effectively treats moderate to severe asthma. It blocks certain processes in the body that cause lung inflammation, a major issue in asthma. Research indicates that dupilumab helps reduce asthma attacks, even when standard treatments like inhalers and other medications are reduced or stopped. In this trial, patients using dupilumab experienced fewer asthma flare-ups compared to those who received a placebo. These findings suggest that dupilumab holds promise for managing asthma symptoms, especially when other treatments aren't fully effective. ^{2 3 4 6 7}

Who Is on the Research Team?

Larry Borish, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

Adults aged 18-40 with mild, well-controlled asthma may join this study. They must have a positive methacholine test, certain blood or breath markers of inflammation, and no recent use of strong immune therapies. Smokers or those with other lung diseases can't participate. Women who can get pregnant must use effective birth control.

Inclusion Criteria

Your blood eosinophil count is 150 or higher, or your FeNO level is 20 or higher.

You have a positive methacholine test with a concentration of 16 milligrams per milliliter or less.

My asthma is managed with albuterol and possibly low to medium dose ICS, without anti-inflammatory meds for sinus issues.

Exclusion Criteria

Members of the clinical site study team and/or his/her immediate family

Pregnant or breastfeeding women

I have had an asthma attack in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dupilumab or placebo and are subsequently exposed to the rhinovirus

2 weeks

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in biomarkers and symptoms

2 weeks

Regular monitoring visits

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The VIA Study is testing if dupilumab prevents worsening asthma symptoms in people with mild to moderate asthma when exposed to the common cold virus (rhinovirus). Participants will receive either dupilumab or a placebo before being exposed to the virus, followed by monitoring through tests and questionnaires.

How Is the Trial Designed?

Group I: Dupilumab Active Control 1 Intervention

The dupilumab dose regimen selected for this study (300 mg q2w after an initial loading dose of 600 mg)

Group II: Placebo Placebo Group 1 Intervention

A harmless substance that looks like the study drug, but which should have no effect. The placebo formulation used in this study contains all the ingredients present in the active drug, except the active ingredient (IL-4α antibody). Therefore, the risk related to this formulation should be no greater than the risk associated to the active drug.

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?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

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

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, 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 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]

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 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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23688323/

Dupilumab in persistent asthma with elevated eosinophil ... Dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations when LABAs and inhaled glucocorticoids were withdrawn, with ...

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. 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02260986

NCT02260986 | Study to Assess the Efficacy and Long- ... Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/​SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (CHRONOS).