Dupilumab for Eczema

Phase 3

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit

Diagnosed active endoparasitic infections or at high risk of these infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 272

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the long-term safety and efficacy of dupilumab, a medication used to treat eczema, in children. The trial will also assess the levels of functional dupilumab in the blood after repeated treatment and the immunogenicity of the medication.

Who is the study for?

This trial is for children aged ≥6 months to <18 years with Atopic Dermatitis (AD) who have participated in a prior dupilumab study. For the sub-study, only kids ≥2 to <12 years old and weighing between 5kg and 60kg can join. Participants must not have severe illnesses or recent treatments that could interfere with the study.

What is being tested?

The main goal is to check long-term safety of dupilumab in young patients with AD. It also looks at how well it works over time, its levels in blood after repeated use, and if bodies react against it. A sub-study tests a pre-filled pen version for safety, dosage levels in blood, and immune response.

What are the potential side effects?

While specific side effects are not listed here, generally Dupilumab may cause injection site reactions, eye issues like redness or itching, cold sores in mouth or throat area; however individual experiences may vary.

Eligibility Criteria

Exclusion Criteria

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

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I haven't taken any experimental drugs recently, except for dupilumab.

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I have or am at high risk for serious worm infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 272

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 272

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 272 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)

OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)

Secondary study objectives

Annualize event rate of AD flares during the study

For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained

Number of AD flares during the study

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