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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 14
Awards & highlights

VIA Trial 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.Check my eligibility
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.See study design
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.

VIA Trial 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.

VIA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in interleukin-25 transcript expression post-rhinovirus inoculation
Secondary outcome measures
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

VIA 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.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,013 Total Patients Enrolled
10 Trials studying Asthma
731 Patients Enrolled for Asthma
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,405 Total Patients Enrolled
28 Trials studying Asthma
11,927 Patients Enrolled for Asthma
Larry Borish, MDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
137 Total Patients Enrolled
2 Trials studying Asthma
100 Patients Enrolled for Asthma

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04380038 — Phase 4
Asthma Research Study Groups: Dupilumab, Placebo
Asthma Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04380038 — Phase 4
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380038 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Dupilumab a reliable treatment for individuals with no adverse effects?

"The clinical data on Dupilumab reveals that it is approved for use, so this medication was given a 3 out of 3 safety rating."

Answered by AI

What is the participant quantity for this scientific trial?

"Affirmative. According to what is posted on clinicaltrials.gov, this medical trial commenced looking for participants on May 1st 2022 and was most recently edited on the 16th of that same month. The research team aims to recruit 60 individuals from a single centre."

Answered by AI

Who meets the criteria for enrollment in this medical research study?

"To be considered for admission, patients must possess asthma and lie between the ages of 18-40. This trial is currently seeking 60 participants."

Answered by AI

Have any previous experiments employed Dupilumab for research?

"At present, there are forty-nine Dupilumab clinical trials with thirteen of them in the most advanced phase of research. These studies have been originating from Palo Alto, California while being conducted at 2602 sites across the country."

Answered by AI

Are there any vacancies remaining in this clinical research?

"Affirmative. The clinicaltrials.gov website demonstrates that this medical trial was initially posted on May 1st 2022 and is actively recruiting for 60 patients at one site."

Answered by AI

Is this the inaugural clinical trial of its kind?

"At this moment, there are 49 active Dupilumab trials being conducted in 436 cities and 43 countries. Sanofi's Phase 3 study of the drug began in 2015, enrolling 880 participants. From that point onwards, 54 trials have been successfully concluded."

Answered by AI

Does the research team accept participants aged under eighty for this experiment?

"This trial is looking for volunteers aged 18 to 40 years old."

Answered by AI

What afflictions are generally addressed by Dupilumab remedies?

"Dupilumab is primarily used to treat dermatitis, atopic and can also be an effective way of managing failure with corticosteroid therapy, eosinophil-related illnesses and asthma."

Answered by AI
~22 spots leftby May 2025