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Eczema drug dupilumab under Real-World microscope: will it hold up?

NCT ID NCT06039241

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 900 people aged 6 and older with atopic dermatitis (eczema) who are taking dupilumab as part of their normal care. Researchers will track symptoms, quality of life, and disease control over two years using questionnaires and checkups. The goal is to see how well dupilumab works in everyday life and to gather long-term safety data.

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 study could confirm that dupilumab works well in everyday settings for managing atopic dermatitis over the long term.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection or concurrent treatments. It does not test a new drug or cure.

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 900 people

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

Started

Mar 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

Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) according to the Summary of Product Characteristics. The decision to initiate treatment with dupilumab will be made by the attending physician based on the patient's medical requirements and standards of best medical practice. This decision will be made independent of and prior to data collection in this non-interventional study (NIS).

Ages

6 years and older

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: * Patients are at least 6 years of age at the baseline visit. * Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics. * Patients or their guardians are able to understand and complete the study-related questionnaires. * Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable. Exclusion Criteria: * Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics. * Patients who have already been treated with dupilumab for more than 7 days. * Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results. * Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study. 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

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

    55 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: 002

    RECRUITING

    Berlin, 10117, Germany

  • Investigational Site Number: 003

    RECRUITING

    Berlin, 10627, Germany

  • Investigational Site Number: 004

    RECRUITING

    Berlin, 13086, Germany

  • Investigational Site Number: 007

    RECRUITING

    Giessen, 35392, Germany

  • Investigational Site Number: 013

    RECRUITING

    Mannheim, 68167, Germany

  • Investigational Site Number: 014

    RECRUITING

    Mainz, 55128, Germany

  • Investigational Site Number: 016

    RECRUITING

    Kiel, 24103, Germany

  • Investigational Site Number: 017

    RECRUITING

    Kiel, 24105, Germany

  • Investigational Site Number: 018

    RECRUITING

    Mölln, 23879, Germany

  • Investigational Site Number: 019

    RECRUITING

    Wismar, 23966, Germany

  • Investigational Site Number: 020

    RECRUITING

    Hamburg, 22303, Germany

  • Investigational Site Number: 024

    RECRUITING

    Oelde, 59302, Germany

  • Investigational Site Number: 026

    RECRUITING

    Dresden, 01277, Germany

  • Investigational Site Number: 028

    RECRUITING

    Chemnitz, 09113, Germany

  • Investigational Site Number: 031

    RECRUITING

    Gladbeck, 45964, Germany

  • Investigational Site Number: 032

    RECRUITING

    Düren, 52349, Germany

  • Investigational Site Number: 035

    RECRUITING

    Mönchengladbach, 41061, Germany

  • Investigational Site Number: 038

    RECRUITING

    Langenau, 89129, Germany

  • Investigational Site Number: 042

    RECRUITING

    Nuremberg, 90419, Germany

  • Investigational Site Number: 043

    RECRUITING

    Erlangen, 91054, Germany

  • Investigational Site Number: 045

    RECRUITING

    Nuremberg, 90402, Germany

  • Investigational Site Number: 047

    RECRUITING

    Wasserburg, 83512, Germany

  • Investigational Site Number: 050

    RECRUITING

    München, 80331, Germany

  • Investigational Site Number: 053

    RECRUITING

    Heilbad Heiligenstadt, 37308, Germany

  • Investigational Site Number: 055

    RECRUITING

    Gera, 07545, Germany

  • Investigational Site Number: 057

    RECRUITING

    Buxtehude, 21614, Germany

  • Investigational Site Number: 059

    RECRUITING

    Braunschweig, 38114, Germany

  • Investigational Site Number: 061

    RECRUITING

    Aachen, 52064, Germany

  • Investigational Site Number: 063

    RECRUITING

    Jülich, 52428, Germany

  • Investigational Site Number: 064

    RECRUITING

    Essen, 45149, Germany

  • Investigational Site Number: 066

    RECRUITING

    Andernach, 56626, Germany

  • Investigational Site Number: 069

    RECRUITING

    Cologne, 50733, Germany

  • Investigational Site Number: 072

    RECRUITING

    Dresden, 01109, Germany

  • Investigational Site Number: 073

    RECRUITING

    Berlin, 13507, Germany

  • Investigational Site Number: 076

    RECRUITING

    Neubrandenburg, 17036, Germany

  • Investigational Site Number: 077

    RECRUITING

    Berlin, 12353, Germany

  • Investigational Site Number: 078

    RECRUITING

    Göttingen, 37075, Germany

  • Investigational Site Number: 082

    RECRUITING

    Potsdam, 14469, Germany

  • Investigational Site Number: 086

    RECRUITING

    Hamburg, 22549, Germany

  • Investigational Site Number: 087

    RECRUITING

    Hamburg, 20249, Germany

  • Investigational Site Number: 088

    RECRUITING

    Hamburg, 22159, Germany

  • Investigational Site Number: 092

    RECRUITING

    Ahaus, 48683, Germany

  • Investigational Site Number: 168

    RECRUITING

    Wittlich, 54516, Germany

  • Investigational Site Number: 169

    RECRUITING

    Heidelberg, 69115, Germany

  • Investigational Site Number: 172

    RECRUITING

    Remscheid, 42897, Germany

  • Investigational Site Number: 174

    RECRUITING

    Berlin, 13403, Germany

  • Investigational Site Number: 176

    RECRUITING

    Berlin, 10997, Germany

  • Investigational Site Number: 177

    RECRUITING

    Rostock, 18055, Germany

  • Investigational Site Number: 178

    RECRUITING

    Mainz, 55116, Germany

  • Investigational Site Number: 179

    RECRUITING

    Leipzig, 04315, Germany

  • Investigational Site Number: 183

    RECRUITING

    Landsberg, 06188, Germany

  • Investigational Site Number: 184

    RECRUITING

    Friedberg, 61169, Germany

  • Investigational Site Number: 185

    RECRUITING

    Mainz, 55116, Germany

  • Investigational Site Number: 186

    RECRUITING

    Karlsruhe, 76133, Germany

  • Investigational Site Number: 193

    RECRUITING

    Wuppertal, 42349, Germany

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