Phase 4 Eczema Trial, Completed NCT05507580 Sponsor: AbbVie Condition: Eczema
Back to Eczema

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 461 participants with atopic dermatitis (eczema) across two groups during the first phase: 229 received a 15 mg dose of upadacitinib (UPA) and 232 received a 30 mg dose, both without participants knowing which dose they were taking. After this first 12-week phase, participants moved into a second phase where they could be switched to a different dose or stay on the same one, creating four subgroups. The trial used a standard eczema scoring tool called the EASI (scored from 0 to 72, where higher numbers mean more severe eczema) to track changes in skin symptoms over time. The reported data shows that at 12 weeks, 64.4% of those on the 15 mg dose and 79.3% on the 30 mg dose had their EASI score reduced by at least 75% from where it started. For a 90% or greater reduction at 12 weeks, the figures were 33.8% (15 mg) and 59.9% (30 mg); and for a complete 100% reduction, 7.7% (15 mg) and 15.9% (30 mg) were reported. By week 24, the reported data shows results varied depending on which dose participants received across both phases. Among those who were on the 15 mg dose throughout both phases, 74.6% had at least a 90% reduction in their EASI score, compared to 29.3% for those on 30 mg throughout. For participants who switched doses between phases, the reported figures fell between these values. Complete clearance (100% reduction) at week 24 ranged from 3.7% to 33.8% depending on the dose pathway followed. 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 4 Eczema Trial, Completed

NCT05507580
Completed Phase 4 🇦🇺 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 have had atopic dermatitis (eczema) for at least 3 years before the start of the study, and your condition meets a standard set of diagnostic criteria for eczema (confirm with trial site).
  • Your eczema is currently rated as moderate to severe based on specific medical scoring measures of how much of your body is affected and how severe it is (confirm with trial site).
  • You have been experiencing significant itching on most days, rating it at least a 4 out of 10 on average over the past week.
  • You are a candidate for treatment that works throughout the whole body, meaning you have either tried such treatments before, have not responded well enough to standard skin creams or ointments, or topical (skin) treatments are not suitable for you for medical reasons.

Who may not be able to join:

  • You have had two or more episodes of shingles (a painful rash caused by the chickenpox virus), or one or more episodes where shingles spread widely across your body.
  • You have had one or more episodes of a widespread herpes simplex infection (including a serious skin condition called eczema herpeticum).
  • You have been diagnosed with HIV.
  • You currently have active tuberculosis (TB), or your TB test results do not meet the study's requirements (confirm with trial site).
  • You are taking part at a site in Japan and have tested positive for a specific fungal infection screening test (confirm with trial site).
  • You have needed intravenous (IV, through a drip) antibiotics or antiviral medicines in the last 30 days, or oral/injected antibiotics or antivirals in the last 14 days, for an active infection.
  • You have a long-term recurring infection or an ongoing viral infection that the study doctor believes makes it unsafe for you to take part.
  • You currently have COVID-19, unless specific recovery conditions have been met — for example, you have been symptom-free for at least 5 days since testing positive, or your fever has gone away on its own and other symptoms have improved (confirm with trial site for exact requirements).
  • You have evidence of a current or past Hepatitis B or Hepatitis C infection.
  • You have had a stroke, heart attack, heart stent procedure, or major heart bypass surgery within the past 6 months.
  • You have had an organ transplant and still need to take medicines to prevent your body from rejecting it.
  • You have had a significant allergic reaction to the study drug or similar medications in the past (confirm with trial site).
  • You have a history of a hole or tear forming in your digestive tract (gut perforation), inflammation of small pouches in your gut (diverticulitis), or are considered at high risk for these conditions.
  • You have a condition that affects how your body absorbs medicines, such as short bowel syndrome or having had gastric bypass surgery (note: gastric banding alone does not exclude you — confirm with trial site).
  • You have a history of cancer, unless it was a minor skin cancer (non-melanoma) that was successfully treated, or an early-stage cervical cell abnormality that was successfully treated.

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 16 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: ABBVIE INC., AbbVie

Australian sites

Momentum Clinical Research /ID# 254028, Darlinghurst, New South Wales
Premier Specialist /ID# 246150, Kogarah, New South Wales
Veracity Clinical Research /ID# 246154, Woolloongabba, Queensland
North Eastern Health Specialists /ID# 246153, Campbelltown, South Australia
Skin Health Institute Inc /ID# 246146, Carlton, 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
Completed
Phase
Phase 4
Sponsor
Registry
ClinicalTrials.gov
Start date
29 May 2023
Est. completion
11 July 2024

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom

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

Primary endpoints

Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 24

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: 16 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