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Atopic DermatitisPhase 4PELISTAD CNNCT05680298

Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
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
34 participants
Where
1 siteChina
Study dates
22 Feb 2023to 15 Mar 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participant must be between ≥6 to <12 years of age inclusive, at the time of signing the informed consent.
  • Male or female.
  • Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
  • Investigator Global Assessment score of ≥3 (for US patients) or IGA ≥4 (for EU patients) at screening (on the 0 to 4 scale) depending on approved label indication in the country.
  • Patients with moderate-to-severe AD 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 to 3 scale of the ISS.
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  • 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 to refrain from showers or soak in a bathtub with soaps and body washes within 6 hours before TEWL assessments.
  • Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas (lesional and non-lesional) during the entire study from Day -7 to Week 28 (EoS).
  • Willing and able to comply with all clinic visits and study-related procedures.
  • 15 kg ≤ body weight <60 kg
  • Age and gender matched (match on age ±2 years) to a selected AD patient by study site.
  • No current dermatologic or systemic condition that could interfere with the assessments.
  • 15 kg ≤ body weight <60 kg
  • Male or female - - - -

Who cannot join

  • Medical conditions
  • 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.
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  • 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.
  • Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
  • History of hypersensitivity reaction to tape or adhesives used in desquamme discs.
  • Patients administered live attenuated vaccines within the 4 weeks prior to the baseline visit or need to receive live (attenuated) vaccinations through Week 28.
  • Prior/concomitant therapy
  • Treatment with an investigational medication within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer.
  • Patients who received a live vaccine within 4 weeks of baseline.
  • Prior/concurrent clinical study experience
  • Current participation in another investigational or interventional clinical study
  • Other exclusions
  • Planned or anticipated major surgical procedure during the patient's participation in this study.
  • Healthy volunteers with a personal history of an atopic condition.
  • Healthy volunteers with use of any topical treatment anywhere except Cetaphil®, Vanicream™, E45 cream or the preferred moisturizer not containing additives on non-targeted skin areas.
  • Female of childbearing potential* and sexually active, who is unwilling to use highly effective methods of contraception prior to the initial dose, during the study and for at least 120 days after the last dose of study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Children's hospital

    Beijing

Other trials in China

About this study

Official title: Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Chinese Pediatric Patients With Moderate-to-severe Atopic Dermatitis

This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and <12 years old), and a 12-week follow-up period. Patients will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 End of Treatment (EoT) phase visit, and every 6-weeks thereafter during the follow-up period and by this will end the study for each participant (End of Study [EoS]). The maximum duration of the study per participant will be 32 weeks (including screening period).

Skin barrier function in approximately 10 healthy volunteers (not more than 20 healthy participants aged ≥6 and <12 years old) matched for age (match on age ±2 years), gender, location of targeted lesion area, and study site to the AD cases will be assessed in a similar manner at baseline, and will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 EoT phase visit, and every 6-weeks thereafter during the follow-up period, serving as a reference comparator for skin barrier function.

Read the detailed description

32 weeks

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 Dupixent

    solution for injection, Subcutaneous injection

Study groups in NCT05680298
Study groupRoleWhat they receive
AD patientsExperimentalPediatric patients (≥6 and <12 years of age) with moderate-to-severe AD will receive a SC injection of dupilumab depending on the body weight
Receives: Drug: Dupilumab
Healthy volunteersNo interventionExcept for IMPs administration, skin barrier function assessments for healthy volunteers are conducted at the same time and in the same measurement conditions as for AD patients.

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 at Week 16 in AD patients.

    Measured: From baseline to week16

Secondary outcomes (1)

  1. Change from baseline in TEWL before and after 10, 15, 20 STS assessed on lesional skin in AD patients at Week 16.

    Measured: From baseline to week16

Timeline

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

  1. First posted11 Jan 2023
  2. Study start22 Feb 2023
  3. Primary completion22 Dec 2023
  4. Study completion15 Mar 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680298
Sponsor's protocol ID
LPS17244
Other IDs
U1111-1272-6639, 2024-000402-15
Acronym
PELISTAD CN
Status last verified
Feb 2025
First submitted
26 Dec 2022
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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 Atopic Dermatitis, run by Sanofi at 1 site in China.

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 16 inclusion and 21 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: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 at Week 16 in AD patients. (time frame: From baseline to week16). 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 NCT05680298.

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 10 Feb 2025.

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