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Dermatitis AtopicPhase 4PELISTAD-EX2NCT05983068

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

A Phase 4 study testing dupilumab in people with Dermatitis Atopic, run by Sanofi at 4 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric… Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Dermatitis Atopic
What is being tested?
dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesin 2 countries
Study dates
22 Feb 2024to 19 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • National Jewish Health Medical Center- Site Number : 8400001

    Denver, Colorado, 80206

  • NYU Langone Medical Center- Site Number : 8400004

    New York, New York, 10016

  • SSM Health Saint Louis University Hospital- Site Number : 8400006

    St Louis, Missouri, 63104

Other trials in United States

United Kingdom1 site

  • Investigational Site Number : 8260001

    Sheffield, S10 2TH

Other trials in United Kingdom

About this study

Official title: A Two-year, Phase 4, Open-label, Single-arm Treatment Study to Evaluate the Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants (≥6 to <15 Years of Age) With Moderate-to-severe Atopic Dermatitis

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 by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and <15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period).

The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab:

  • Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to <12 years at study entry)
  • Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study [PELISTAD/LPS16764] who consent to participate in this long-term study; aged ≥6 to <15 years at entry to this study)
Read the 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 treatment period: 104 weeks (from Day 1/Week 0 to Week 104).
  • Follow-up period: 4 weeks (safety follow-up phone visit at 4 weeks after the EoT visit).
Being tested
dupilumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dupilumabDrug

    Also called REGN668

    solution for injection; by subcutaneous (SC) injection

Study groups in NCT05983068
Study groupRoleWhat they receive
Pediatric AD participantsExperimentalParticipants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.
Receives: Drug: dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline to Week 104

Secondary outcomes (2)

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

    Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS, respectively, assessed on lesional skin at each study visit

    Measured: Baseline to Week 104

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

    Measured: Baseline to Week 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start22 Feb 2024
  3. Primary completion29 Apr 2027 (estimated)
  4. Study completion19 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983068
Sponsor's protocol ID
LPS17764
Other IDs
U1111-1280-5813
Acronym
PELISTAD-EX2
Status last verified
Apr 2026
First submitted
1 Aug 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dupilumab in people with Dermatitis Atopic, run by Sanofi at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in TEWL after 5 STS assessed on lesional skin. (time frame: Baseline to Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05983068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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