NCT06389136 · AbbVie
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
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What this study is about
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the effectiveness and safety of upadacitinib at different doses in adult participants with moderate to severe AD.
View original scientific description
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD).
Interventions
DRUG
Upadacitinib 15mg Dose
Oral tablet
DRUG
Dupilumab 300mg Dose
Subcutaneous (SC) injection
DRUG
Upadacitinib 30mg Dose
Oral tablet
Primary outcome measures
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90)
Time frame: At Week 8
The EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.
- Participant meets all the following disease activity criteria at Baseline Visit:
- Eczema Area and Severity Index (EASI) score \>= 12;
- validated Investigator´s Global Assessment for AD (vIGA-AD) score \>= 3;
- Body surface area (BSA) involvement of \>= 10% in a majority of subjects (\>= 50% of the overall study population)
- Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS) \>= 4. Note: The Baseline weekly average of daily WP-NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed.
- Inadequate response to dupilumab treatment after at least 4 months of current use.
- Particpant has applied a topical emollient (an additive-free, bland emollient moisturizer) twice daily for at least 7 days before the Baseline Visit
Where
- Birmingham, Alabama
- Scottsdale, Arizona
- Fayetteville, Arkansas
- Chula Vista, California
- Encino, California
- Fountain Valley, California
- Greenbrae, California
- Mission Viejo, California
- Oceanside, California
- Pasadena, California
- Redwood City, California
- Sacramento, California
And 61 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations