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New study tracks Dupilumab's Real-Life impact on kids with severe eczema

NCT ID NCT06415175

Knowledge-focused Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 143 children aged 6 months to 11 years with severe atopic dermatitis (eczema) who are starting treatment with dupilumab in Spain. Researchers will observe how the drug is used in everyday practice, its effectiveness, and any side effects over two years. No extra treatments or tests are given beyond standard care.

What this could mean

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

Active substance
Dupilumab
What this could lead to
If successful, this could provide real-world evidence on how well dupilumab works for severe eczema in young children, helping guide treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the drug. It only includes children in Spain, so findings may not apply everywhere.

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

143 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Nov 2027

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

Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.

Ages

6 months to 11 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 6 months to 11 years old at baseline. * Patients with severe Atopic dermatitis (AD) according to the investigator's assessment. * Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records). * Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age. Exclusion Criteria: * Patients who are participating in an interventional clinical trial that modifies patient care. The above information is not intended to contain all considerations relevant to a patient's 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

Contacts and locations

Locations

  • Investigational Site Number : 7240001

    Madrid, 28007, Spain

  • Investigational Site Number : 7240002

    Alicante, 03010, Spain

  • Investigational Site Number : 7240003

    Barcelona, 08041, Spain

  • Investigational Site Number : 7240004

    Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

  • Investigational Site Number : 7240005

    Oviedo, Principality of Asturias, 33011, Spain

  • Investigational Site Number : 7240006

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Investigational Site Number : 7240007

    Madrid, 28031, Spain

  • Investigational Site Number : 7240008

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7240009

    San Cristóbal de La Laguna, 38320, Spain

  • Investigational Site Number : 7240010

    Madrid, 28009, Spain

  • Investigational Site Number : 7240011

    Zaragoza, 50009, Spain

  • Investigational Site Number : 7240012

    Palma, 07120, Spain

  • Investigational Site Number : 7240013

    Málaga, 29010, Spain

  • Investigational Site Number : 7240014

    Madrid, 28046, Spain

  • Investigational Site Number : 7240016

    Valencia, 46026, Spain

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