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Can a drug calm severe eczema itch when the rash is mild? a new study investigates

NCT ID NCT06192563

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study looks at teenagers aged 12 to 17 who have severe atopic dermatitis (eczema) with intense itching but only a mild to moderate rash. They are being treated with dupilumab (Dupixent), a standard medication. The goal is to see how well dupilumab controls itching, improves sleep and quality of life, and affects eczema in sensitive areas like the face, hands, and genitals. Researchers will follow participants for 52 weeks to track these outcomes in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If successful, this could show that dupilumab helps teens with severe itching even when their eczema rash is not widespread, improving sleep, daily life, and sensitive skin areas.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also limited to a specific group of teens in Italy, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric (aged 6 months to 17 years) participants who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, aged between 6 months and 17 years at the baseline visit. * Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria: \-- Adolescents (12 to 17 years old) with EASI \< 16 and children (6 months to 11 years of age) with EASI \< 21 and. 1. Children's Dermatology Life Quality Index (cDLQI)\* ≥ 10 and / or 2. Itch NRS ≥ 7 and / or 3. Localization in visible or sensitive areas (head/neck/hands or genitals) * Participants/ caregivers able to understand and complete study-related questionnaires. * Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable. * Only for adolescents and children 6-11 years of age. Exclusion Criteria: * Use of dupilumab within 6 months prior to study entry. * Participants currently participating in any interventional clinical trial that modifies patient care. * Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse). The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis Dermatitis, atopic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number: 001

    RECRUITING

    Milan, 20122, Italy

  • Investigational Site Number: 002

    RECRUITING

    Bologna, 40138, Italy

  • Investigational Site Number: 004

    RECRUITING

    Florence, 50139, Italy

  • Investigational Site Number: 005

    RECRUITING

    Roma, 00133, Italy

  • Investigational Site Number: 006

    RECRUITING

    Brescia, 25123, Italy

  • Investigational Site Number: 009

    RECRUITING

    Roma, 00168, Italy

  • Investigational Site Number: 010

    RECRUITING

    Naples, 80131, Italy

  • Investigational Site Number: 011

    RECRUITING

    Naples, 80138, Italy

  • Investigational Site Number: 014

    RECRUITING

    Verona, 37134, Italy

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