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Monoclonal Antibodies

Dupilumab for Asthma (VIA Trial)

Phase 4

Recruiting

Led By Larry Borish, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Well controlled asthma on albuterol alone or albuterol plus low to medium dose inhaled corticosteroids (ICS) with or without other controller medications not using any anti-inflammatory medications for any concurrent sinonasal conditions

Physician diagnosed asthma for at least 6 months

Must not have

History or clinical evidence of COPD or any other significant lung disease

Use of any inhaled nasal sprays

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to day 14

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether the drug dupilumab can help prevent people with mild to moderate asthma from having increased symptoms after being exposed to the common cold virus.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dupilumab might cause side effects like injection site reactions, headache, fatigue, joint pain or allergic reactions. Since it affects the immune system, there could also be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with asthma for over 6 months.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have COPD or another serious lung condition.

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I use inhaled nasal sprays.

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I have had an asthma attack that needed a doctor's visit or steroids in the last 3 years.

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I have been hospitalized or visited the ER for severe asthma attacks.

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I have smoked for more than 10 years and over 10 pack-years.

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I have taken asthma biologic therapy, like dupilumab, in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in interleukin-25 transcript expression post-rhinovirus inoculation

Secondary study objectives

Change in allergen-specific Th2 effector lymphocytes post-rhinovirus inoculation

Change in symptoms post-rhinovirus inoculation

Change in the proteome in nasal wash samples post-rhinovirus inoculation

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DupilumabActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 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.

0 / 9Eligibility criteria met