Phase 3 Eczema Trial, Completed NCT06238817 Sponsor: Incyte Corporation Condition: Eczema
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial enrolled 241 participants across two main groups: 81 people received a vehicle cream (an inactive cream with no active ingredient, used as a comparison) and 160 people received ruxolitinib 1.5% cream (the treatment being studied). The trial was measuring changes in eczema (atopic dermatitis) severity over 8 weeks, using two main scoring tools — one called EASI, which rates the physical signs of eczema on a scale of 0 to 72, and another called IGA, which gives an overall severity rating from 0 (clear) to 4 (severe). The reported data shows that at the 8-week mark, 70.0% of participants in the ruxolitinib cream group had their EASI score improve by 75% or more from where it started, compared with 18.5% of participants in the vehicle cream group. For the IGA measure, 61.3% of those using ruxolitinib cream achieved a score of 0 or 1 (meaning clear or almost clear skin) with at least a 2-grade improvement from their starting score, compared with 13.6% in the vehicle cream group. The reported data for the secondary outcome measures — including itch scores and adverse event (side effect) counts — was not provided in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Eczema Trial, Completed

NCT06238817
Completed 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 18 years old or older (note: in Korea, you must be 19 or older)
  • You have been diagnosed with atopic dermatitis (eczema) using standard medical criteria
  • You have had atopic dermatitis for at least 2 years
  • Your atopic dermatitis has been rated as "moderate" by a doctor at both the screening visit and the start of the study (Day 1)
  • Your eczema severity score is above a certain level at both the screening visit and Day 1 (confirm with trial site)
  • Your itch level, rated on a scale, averages 4 or higher over the 7 days before Day 1, with at least 4 days of recorded scores
  • Between 10% and 20% of your body surface area (not including the scalp) is affected by eczema at both the screening visit and Day 1
  • Your quality of life is significantly affected by your eczema, as measured by a standard questionnaire score above 10
  • In the past 12 months, standard prescription skin creams or ointments for eczema either did not work well enough for you, caused problems, or were not suitable for you
  • You agree to stop using all other eczema treatments from the screening visit through to your final follow-up appointment, except those allowed by the study
  • You agree to take steps to avoid becoming pregnant or causing a pregnancy during the study, as outlined by the study

Who may not be able to join:

  • Your eczema has been getting significantly better or worse on its own in the 4 weeks before Day 1, as judged by the doctor
  • You have a condition that weakens your immune system, such as lymphoma, AIDS, or certain rare immune disorders
  • You have had a serious infection requiring prescription antibiotics, antivirals, or antifungal medicines taken by mouth or injection within 2 weeks before Day 1
  • You have an active bacterial, fungal, or viral skin infection (such as cold sores, shingles, or chickenpox) within 1 week before Day 1
  • You have another skin condition that could make it hard to assess your eczema or affect your safety, in the doctor's opinion
  • Your eczema only affects your hands or feet, and you have no history of it affecting other typical areas like the face or skin folds
  • You have had another type of eczema in the 6 months before screening (seborrheic dermatitis on the scalp is allowed)
  • You have a current or past hepatitis B or C infection
  • You have any serious illness — physical or mental — that, in the doctor's opinion, would prevent you from fully taking part in the study or put you at significant risk
  • Your blood test results at screening show low hemoglobin (below 10 g/dL), poor liver function, poor kidney function, or a positive HIV test
  • Any other blood test result that the doctor considers a significant health risk
  • You have recently used certain medicines, including biologic injections, steroid tablets, immune-suppressing drugs, or strong CYP3A4 inhibitor medicines, without enough time having passed since stopping them (the required waiting period varies by medication — confirm with trial site)
  • You have used certain topical (applied to skin) eczema treatments within 1 week before Day 1, such as steroid creams, calcineurin inhibitor creams, or antibiotic creams (plain moisturisers are allowed)
  • You have previously tried a JAK inhibitor medicine (such as ruxolitinib, baricitinib, abrocitinib, or upadacitinib) for eczema or another inflammatory condition and it did not work
  • You have had UV light therapy or significant sun or tanning bed exposure within 2 weeks before the start of the study, or you plan to during the study in a way that might affect your eczema
  • You are currently taking part in another clinical trial or have taken an experimental medicine within the past 30 days or 5 half-lives of that medicine (whichever is longer)
  • In the doctor's opinion, you are unlikely or unable to follow the study schedule, complete required diaries, or attend all required visits

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 26 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: Incyte Medical Monitor, Incyte Corporation

Australian sites

Premier Specialists Pty Ltd, Kogarah, New South Wales
Australian Clinical Research Network, Maroubra, New South Wales
Veracity Clinical Research, Woolloongabba, Queensland
Clinical Trials Sa, Campbelltown, South Australia
Skin Health Institute Inc., Carlton, Victoria
Paratus Clinical Research, Woden, Phillip,

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
Completed
Phase
Phase 3
Sponsor
Incyte Corporation
Registry
ClinicalTrials.gov
Start date
26 April 2024
Est. completion
21 May 2025

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8; Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8

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: 26 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