Status:
ACTIVE_NOT_RECRUITING
A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
Brief Summary
This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured ...
Detailed Description
Study duration for each participant will be approximately 112 weeks, including: * Screening period: Up to 4 weeks (Day -28 to Day -1) from signing the informed consent. * Open-label dupilumab treatme...
Eligibility Criteria
Inclusion
- 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.
- Type of participant and disease characteristics
- With AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
- Applicable to new participants only: Validated Investigator Global Assessment for AD (vIGA AD™) score of ≥3 (for US and Canada participants) or ≥4 (for UK participants) at screening (on the 0 to 4 scale) depending on the approved vIGA-AD™ label indication in the country.
- Applicable to new participants only: 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 to 3 scale of the ISS.
- Applicable to all 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.
- Willing to refrain from applying any topical medications on the target assessment areas (including lesional and non-lesional) throughout the study until EoS unless necessary to alleviate intolerable symptoms.
- Willing and able to comply with all clinic visits and study-related procedures. Weight
- Body weight ≥15 kg at screening.
Exclusion
- Medical conditions
- 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.
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
- History of hypersensitivity reaction to skin tape or adhesives used in tape strip discs.
- Prior/concomitant therapy
- Treatment with any investigational medication other than dupilumab within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer.
- 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.
- Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the Investigator.
- Participants who received a live vaccine within 4 weeks of baseline. Prior/concurrent clinical study experience
- Current participation in another investigational or interventional clinical study.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 7 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05983068
Start Date
February 22 2024
End Date
August 7 2026
Last Update
May 15 2025
Active Locations (4)
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1
National Jewish Health Medical Center- Site Number : 8400001
Denver, Colorado, United States, 80206
2
SSM Health Saint Louis University Hospital- Site Number : 8400006
St Louis, Missouri, United States, 63104
3
NYU Langone Medical Center- Site Number : 8400004
New York, New York, United States, 10016
4
Investigational Site Number : 8260001
Sheffield, United Kingdom, S10 2TH