Phase 3 Eczema Trial, Recruiting NCT06311682 Sponsor: LEO Pharma Condition: Eczema
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Phase 3 Eczema Trial, Recruiting

NCT06311682
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 6 months to under 12 years old at the time of screening
  • Children weighing at least 9 kg at screening
  • Children who have been formally diagnosed with atopic dermatitis (eczema) using a recognised set of diagnostic criteria
  • Children who have had atopic dermatitis for at least 12 months (for those aged 6 years and older) or at least 3 months (for those aged 6 months to under 6 years)
  • Children whose eczema did not respond well enough to medium-strength steroid creams within the 6 months before screening
  • Children whose eczema covers at least 10% of their body surface area at both the screening and baseline visits
  • Children whose eczema severity scores (EASI and IGA) meet certain minimum thresholds at both the screening and baseline visits (confirm with trial site for exact score details)
  • Children aged 6 and over who have reported significant itching in the week before the baseline visit, or children under 6 who have shown significant scratching behaviour in that same period (confirm with trial site)

Who may not be able to join:

  • Children who have used certain topical (applied to the skin) treatments — including steroid creams, calcineurin inhibitors, PDE-4 inhibitors, or JAK inhibitors — within 1 week before the baseline visit
  • Children who have had bleach baths within 1 week before the baseline visit
  • Children who have taken certain immune-suppressing or immune-modifying medications by mouth or injection, or oral/injected steroids, within 4 weeks before the baseline visit
  • Children who have used tanning beds or light therapy (phototherapy) within 4 weeks before the baseline visit
  • Children who have received any live or non-live vaccine within 30 days before the baseline visit
  • Children who have another active skin condition that could be confused with eczema or interfere with assessment, such as seborrheic dermatitis, an active skin infection, scabies, a type of skin lymphoma, or psoriasis
  • Children who have a significant active infection currently being treated with antibiotics, antivirals, antifungals, or antiprotozoal medicines within 2 weeks before the baseline visit
  • Children with a history of hepatitis B or C, or who test positive for hepatitis B or C at screening

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Expert, LEO Pharma

Phone: +45 4494 5888

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
LEO Pharma
Registry
ClinicalTrials.gov
Start date
10 June 2024
Est. completion
20 October 2026

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇭🇷 Croatia 🇩🇪 Germany 🇮🇪 Ireland 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.; Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov