Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis (PELISTAD)

  • STATUS
    Recruiting
  • End date
    Oct 13, 2022
  • participants needed
    48
  • sponsor
    Sanofi
Updated on 13 May 2022
erythema
dupilumab
Accepts healthy volunteers

Summary

Primary Objective:

  • Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric patients with moderate to severe atopic dermatitis (AD) treated with dupilumab

Secondary Objectives:

  • Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non lesional skin in pediatric patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.
  • Evaluate time course of change in skin barrier function with TEWL assessed before and after STS in predefined lesional and non-lesional skin in pediatric patients with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers

Description

Total study duration including screening and follow-up will be 32 weeks

Details
Condition Dermatitis Atopic
Treatment Dupilumab SAR231893
Clinical Study IdentifierNCT04718870
SponsorSanofi
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be between ≥6 to <12 years of age (inclusive), at the time of signing the informed consent
kg ≤ body weight <60 kg
Atopic dermatitis patients
Male or female pediatric patients
Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening
Investigator Global Assessment (IGA) score of ≥3 (for US patients) or IGA ≥4 (for EU patients) at screening (on the 0-4 scale) depending on approved label indication in the country
Patients with moderate to severe AD those are eligible to be treated with dupilumab according to product label
Patients with AD must have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0-3 scale of the Individual Signs Score
Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible
Healthy volunteers
Age and gender matched (match on age ±2 years) to a selected AD patient by study site

Exclusion Criteria

Previous treatment with dupilumab within 6 months prior to screening
Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis)
Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments
Hypersensitivity to the active substance or to any of the excipients of dupilumab
Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited toindividuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca, or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine
Healthy volunteers with a personal history of an atopic condition
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note