← Back to Search

Monoclonal Antibodies

Pediatric AD participants for Atopic Dermatitis (PELISTAD-EX2 Trial)

Q: What is the total number of individuals participating in this clinical investigation?

Affirmative. Information sourced from clinicaltrials.gov indicates that this investigation is currently seeking eligible candidates. The trial was initially disclosed on January 31st, 2024 and underwent its most recent update on February 1st, 2024. A total of 48 subjects are sought across a single designated site for participation in the study.

Q: Are there any available positions for patients in this ongoing clinical trial?

Indeed, records on clinicaltrials.gov show that this investigation is currently in search of suitable participants. Initially shared on January 31st, 2024, the latest modifications were made on February 1st, 2024. The study seeks to enroll a total of 48 patients from one designated site.

Q: Is there an age threshold for potential participants in this research study?

Individuals aged between 6 and 14 years are eligible to participate in this research study. Among <a href="https://www.withpower.com/clinical-trials/all">all</a> ongoing trials, there are a total of 85 studies focusing on participants under the age of 18, while 167 trials target individuals above the age of retirement.

Q: What are the risks associated with Pediatric Atopic Dermatitis participants in terms of patient safety?

Our team at Power assesses the safety of Pediatric AD participants as 3 on a scale up to 3 due to this trial being in Phase 4, denoting an approved treatment status.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 108

Awards & highlights

PELISTAD-EX2 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.Check my eligibility

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.See study design

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.

PELISTAD-EX2 Trial 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.

PELISTAD-EX2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 108

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 108

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 108 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in TEWL after 5 STS assessed on lesional skin.

Secondary outcome measures

Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.

Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the study.

Side effects data

From 2023 Phase 4 trial • 40 Patients • NCT04203797

Sinus pain

Rhinitis

Asthma

Immunisation reaction

Injection site erythema

Cough

100%

80%

60%

40%

20%

Study treatment Arm

Dupilumab 300 mg Q2W

Placebo

PELISTAD-EX2 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

2022

Completed Phase 4

~330

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,932 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

622 Previous Clinical Trials

380,683 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,790 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of individuals participating in this clinical investigation?

"Affirmative. Information sourced from clinicaltrials.gov indicates that this investigation is currently seeking eligible candidates. The trial was initially disclosed on January 31st, 2024 and underwent its most recent update on February 1st, 2024. A total of 48 subjects are sought across a single designated site for participation in the study."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, records on clinicaltrials.gov show that this investigation is currently in search of suitable participants. Initially shared on January 31st, 2024, the latest modifications were made on February 1st, 2024. The study seeks to enroll a total of 48 patients from one designated site."

Answered by AI

Is there an age threshold for potential participants in this research study?

"Individuals aged between 6 and 14 years are eligible to participate in this research study. Among all ongoing trials, there are a total of 85 studies focusing on participants under the age of 18, while 167 trials target individuals above the age of retirement."

Answered by AI

What are the risks associated with Pediatric Atopic Dermatitis participants in terms of patient safety?

"Our team at Power assesses the safety of Pediatric AD participants as 3 on a scale up to 3 due to this trial being in Phase 4, denoting an approved treatment status."

Answered by AI