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Monoclonal Antibodies

Dupilumab for Atopic Dermatitis

Phase 4

Recruiting

Led By Anna B Fishbein, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

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

Must have

Participants, 6-17 years old at time of enrollment

Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist

Must not have

Unable to communicate in English (some PROMIS questionnaires not available in translation)

Use of systemic immunosuppressant within 30 days of first PSG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether the drug dupilumab can improve sleep, itchiness, and circadian function in children 6-17 years old.

Who is the study for?

Children aged 6-17 with moderate to severe atopic dermatitis (AD) that isn't well-controlled by topical treatments can join. They must have a history of sleep disturbances due to AD and be on stable medication regimens. Kids who've used certain meds recently, have other conditions affecting sleep, or cannot communicate in English are excluded.

What is being tested?

The trial is testing Dupilumab's effects over 12 weeks on improving circadian function, sleep quality, and itchiness in children with AD. It's an open-label study where all participants know they're receiving the drug and their sleep and itching symptoms are monitored before and after treatment.

What are the potential side effects?

Dupilumab may cause side effects such as injection site reactions, eye problems like dryness or inflammation, cold sores in your mouth or throat area. Some people might experience headaches or joint pain as well.

Eligibility Criteria

Inclusion Criteria

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

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I am between 6 and 17 years old.

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My eczema is severe and not controlled by creams or ointments.

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My skin condition is rated as moderate or severe.

Exclusion Criteria

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

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I can communicate in English.

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I haven't taken any immune-weakening drugs in the last 30 days.

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I am clinically blind.

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My asthma is not well-managed.

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I have a major medical condition like cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score

PROMIS patient score

Wake After Sleep Onset

Secondary study objectives

Amplitude of Melatonin

Amplitude of Skin Barrier Hydration

CD4+CLA+ and CD8+CLA+ Transcriptome Changes

+25 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Dupilumab/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

1Treatment groups

Experimental Treatment

Group I: Dupilumab administrationExperimental Treatment1 Intervention

dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 8Eligibility criteria met