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Monoclonal Antibodies

Dupilumab for Asthma

Phase 4

Recruiting

Research Sponsored by Sally E. Wenzel MD

Eligibility Criteria Checklist

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

Must have

Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller

Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)

Must not have

History of non-skin cell cancer in the last 5 years

Respiratory infection in the last 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from baseline to 12 weeks after start of treatment

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test whether the drug dupilumab can improve mucus clearance in asthma patients.

Who is the study for?

Adults over 18 with moderate to severe asthma, who are on high doses of inhaled steroids and have specific markers indicating poor lung function (like low FEV1/FVC or high blood eosinophils). They shouldn't be very overweight, have had certain cancers recently, respiratory infections or used specific asthma drugs lately. Smokers and pregnant women are excluded.

What is being tested?

The study is testing the effects of Dupilumab versus a placebo on how well the lungs clear mucus in patients with moderate to severe asthma. It's a controlled trial where participants are randomly chosen to receive either Dupilumab or an inactive substance.

What are the potential side effects?

Dupilumab may cause injection site reactions, eye problems like redness and itching, joint pain, and allergic reactions. Some people might experience cold sores or worsening of existing parasitic infections.

Eligibility Criteria

Inclusion Criteria

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

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My asthma is severe, and I'm on a medium to high dose of inhaled steroids.

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I use inhaled steroids, 500mcg or more daily.

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I am older than 18 years.

Exclusion Criteria

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

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I have not had any cancer other than skin cancer in the past 5 years.

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I have not had a respiratory infection in the last 30 days.

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I have not taken antibiotics or oral prednisone in the last 30 days.

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I am currently using or have recently used anti-IL-5 medication.

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I currently smoke or have a history of heavy smoking.

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I have used dupilumab.

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I have been diagnosed with a lung disease such as COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 12 weeks after the start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 12 weeks after the start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 12 weeks after the start of treatment 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 mucociliary clearance (MCC) rate

Secondary study objectives

Change in ACT score

Change in FEV1% predicted

Change in mucus plugging score by CT

+3 more

Awards & Highlights

Drug Has Already Been Approved

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

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DupilumabActive Control1 Intervention

Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.

Group II: PlaceboPlacebo Group1 Intervention

Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.

0 / 10Eligibility criteria met