Phase 3 Eczema Trial, Completed NCT04345367 Sponsor: Pfizer 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 (NCT04345367) enrolled 727 adults with atopic dermatitis (eczema) — 362 in the abrocitinib group (a once-daily tablet) and 365 in the dupilumab group (an injection given every two weeks). The study was measuring two main things at early timepoints: how quickly each treatment reduced itch (scored on a 0–10 scale, where higher means worse), and how many participants saw a 90% or greater improvement in the overall area and severity of their eczema by week 4. The reported data shows that for the primary outcomes, 48.2% of participants in the abrocitinib group and 25.5% in the dupilumab group reported at least a 4-point drop in their worst itch score by week 2. For eczema area and severity, 28.5% of the abrocitinib group and 14.6% of the dupilumab group reached a 90% or greater improvement by week 4. As the study continued, the reported data shows the gap between the two groups appeared to narrow over time: by week 26, 54.6% of the abrocitinib group and 47.6% of the dupilumab group had reached that 90% improvement mark. Similarly, the percentage of participants whose skin was rated "clear" or "almost clear" by a clinician rose over the 26-week period — reaching 60.0% for abrocitinib and 50.8% for dupilumab by week 26, according to the reported figures. The reported data also shows that for a slightly lower threshold — a 75% or greater improvement in eczema area and severity — 76.1% of the abrocitinib group and 71.1% of the dupilumab group met that level by week 26. These are summary numbers from the trial as a whole; the data submitted did not break results down by individual characteristics such as age or disease history. 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

NCT04345367
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 of age or older
  • You have been diagnosed with long-term (chronic) atopic dermatitis (eczema) for at least 6 months
  • Your eczema is considered moderate to severe, based on scores measured by your doctor across several standard rating scales (confirm with trial site)
  • Your eczema has not responded well enough to medicated creams or ointments, or you have needed oral/injectable medications to manage it

Who may not be able to join:

  • You have a serious ongoing or sudden medical condition, or abnormal lab results, that could make participation risky
  • You have a higher-than-normal risk of developing blood clots in your veins
  • You are unwilling or unable to stop your current eczema medications before or during the study, or you need to take medications that are not allowed in the trial
  • You have previously been treated with certain specific types of medications for eczema, including JAK inhibitors or biologics such as dupilumab (Dupixent), lebrikizumab, or tralokinumab
  • You have another active skin condition or inflammatory skin disease other than eczema
  • You have a medical history that includes blood-related disorders, certain cancers, certain infections, or other serious conditions (confirm with trial site for full details)
  • You are pregnant, breastfeeding, or able to become pregnant but unwilling to use contraception during the study

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: Pfizer CT.gov Call Center, Pfizer

Australian sites

St George Dermatology and Skin Cancer Centre, Kogarah, New South Wales
Royal North Shore Hospital, St Leonards, New South Wales
Box Hill Hospital, Box Hill, Victoria
Emeritus Research, Camberwell, Victoria
Skin Health Institute Inc., Carlton, Victoria
Sinclair Dermatology, East Melbourne, Victoria
Melbourne Health Radiology, Pakrville, Victoria
The Royal Melbourne Hospital, Parkville, Victoria

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
11 June 2020
Est. completion
13 July 2021

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇫🇮 Finland 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇱🇻 Latvia 🇵🇱 Poland 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2; Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

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