Phase 3 Eczema Trial, Recruiting NCT06241118 Sponsor: Sanofi Condition: Eczema
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Phase 3 Eczema Trial, Recruiting

NCT06241118
Recruiting Phase 3 🇦🇺 Australian site

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:

  • You are at least 12 years old at the time of signing the consent form
  • You have been diagnosed with atopic dermatitis (eczema) for at least 1 year, based on standard medical guidelines
  • You have previously tried a biologic medication or a JAK inhibitor pill for atopic dermatitis and it did not work well enough
  • Your eczema is rated as moderate to severe (a score of 3 or 4) by a doctor at the start of the trial
  • Your eczema severity score (called EASI) is 16 or higher at the start of the trial
  • Your eczema covers 10% or more of your body surface area at the start of the trial
  • Your itch, measured by a daily score averaged over a week, is rated 4 or higher at the start of the trial
  • You are able and willing to attend required study visits and follow study procedures
  • You weigh at least 25 kg (approximately 55 lbs)

Who may not be able to join:

  • You have another skin condition that would make it difficult to assess your eczema properly
  • You have a known or suspected condition that significantly weakens your immune system
  • You have or have had any form of cancer, except for a certain type of non-melanoma skin cancer that was fully removed and cured more than 5 years ago
  • You have previously had a solid organ transplant (such as a kidney or liver) or a stem cell transplant
  • You currently have an active or ongoing infection, including a parasitic worm infection, that required treatment with medicines taken by mouth or injection within the 4 weeks before the trial starts
  • You tested positive for HIV, Hepatitis B, or Hepatitis C at the screening visit
  • You have active or latent tuberculosis (TB), a history of TB that was not fully treated, or are considered at high risk of getting TB
  • You have received certain specified treatments within specific timeframes before the trial starts (confirm with trial site for the full list)
  • You have abnormal lab test results that the investigator considers clinically significant at screening
  • You have a known allergy or sensitivity to any ingredient in the study medication

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 15 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

Phone: 800-633-1610

Australian sites

Investigational Site Number : 0360008, Melbourne, Victoria
Investigational Site Number : 0360006, Melbourne, Victoria

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
Registry
ClinicalTrials.gov
Start date
29 February 2024
Est. completion
30 September 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland Reunion 🇸🇦 Saudi Arabia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇦🇪 United Arab Emirates 🇬🇧 United Kingdom 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36; EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36; US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36

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: 15 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