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Monoclonal Antibodies

Dupilumab for Eczema (PELISTAD-EX2 Trial)

Phase 4
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: For new participants: ≥6 to <12 years of age (inclusive), at the time of signing the informed consent. For former PELISTAD participants: ≥6 to <15 years of age at the time of signing the informed consent.
Should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area.
Must not have
Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments.
Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors or phototherapy within 4 weeks of baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 104
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is a 2-year study to see how well Dupixent works on improving skin barrier function in children with moderate-to-severe atopic dermatitis (AD). Around 48 children between

Who is the study for?
This trial is for children aged 6 to under 15 with moderate-to-severe atopic dermatitis (eczema). They must meet specific criteria including having had the condition for at least a year and, if new participants, have certain severity in skin lesions. Participants need to be able to avoid topical medications on target areas during the study unless absolutely needed.
What is being tested?
The trial tests Dupilumab's long-term effects on skin barrier function in pediatric patients with eczema over a period of two years. It measures how well the skin retains moisture before and after a procedure that stresses the skin. All participants will receive Dupilumab according to local guidelines.
What are the potential side effects?
Dupilumab may cause side effects such as injection site reactions, eye problems like redness or itching, cold sores in your mouth or throat, and inflammation of blood vessels. Not all children will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 12 years old, or was part of PELISTAD and am now under 15.
Select...
I have normal skin at least 4 cm away from my affected area.
Select...
My body weight is at least 15 kg.
Select...
I have severe skin redness or swelling on my arms or legs.
Select...
I am between 6 and 12 years old.
Select...
I can attend all clinic visits and follow study procedures. I weigh at least 15 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My skin condition doesn't have open or bleeding wounds in the area to be tested.
Select...
I haven't taken specific immune system medications or undergone phototherapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
Secondary study objectives
Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.

Side effects data

From 2023 Phase 4 trial • 40 Patients • NCT04203797
5%
Asthma
5%
Rhinitis
5%
Injection site erythema
5%
Immunisation reaction
5%
Cough
5%
Sinus pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dupilumab 300 mg Q2W
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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

1Treatment groups
Experimental Treatment
Group I: Pediatric AD participantsExperimental Treatment1 Intervention
Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2023
Completed Phase 4
~470

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,199 Previous Clinical Trials
4,036,239 Total Patients Enrolled
43 Trials studying Eczema
16,023 Patients Enrolled for Eczema
Regeneron PharmaceuticalsIndustry Sponsor
665 Previous Clinical Trials
385,693 Total Patients Enrolled
36 Trials studying Eczema
13,375 Patients Enrolled for Eczema
Clinical Sciences & OperationsStudy DirectorSanofi
872 Previous Clinical Trials
2,020,744 Total Patients Enrolled
11 Trials studying Eczema
1,325 Patients Enrolled for Eczema
~32 spots leftby May 2026
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