Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Dupilumab for Atopic Dermatitis

In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated.

Official registry: https://clinicaltrials.gov/study/NCT06192563 · Sanofi · enrollment listed as 230

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 230 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16 for Adolescents and < 21 for Children) Receiving Dupilumab

Interventions: Dupilumab

Primary outcome (registry wording): Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score

Who it is for (from inclusion criteria)

  • Ages 6 Months to 17 Years
  • 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
  • Children's Dermatology Life Quality Index (cDLQI)\* ≥ 10 and / or
  • Itch NRS ≥ 7 and / or
  • Localization in visible or sensitive areas (head/neck/hands or genitals)
  • Only for adolescents and children 6-11 years of age

Public study contact (from the registry)

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

contact-us@sanofi.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

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FAQ about this NCT record

Is NCT06192563 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06192563?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06192563?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary