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Upadacitinib for Moderate-to-Severe Atopic Dermatitis with Inadequate Response to Dupilumab

This study is for adults aged 18-63 with moderate-to-severe atopic dermatitis (AD), a skin condition causing rash and itching, who haven't responded well to Dupilumab. It's testing the safety and effectiveness of Upadacitinib, an approved medication for AD, at different doses. You would be randomly assigned to receive either Upadacitinib 15mg or Dupilumab 300mg. If you're in the Upadacitinib 15mg group, your dose might be increased to 30mg after two weeks, depending on how you respond. The study aims to see if participants achieve at least a 90% improvement in their eczema severity (EASI 90) by Week 8. The study plans to enroll 200 participants.

Study design
This is an interventional study where participants are randomly assigned to one of two treatment groups: Upadacitinib 15mg or Dupilumab 300mg. The study is conducted in two periods.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 8, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06389136

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Recruiting
PHASE3Ages 18–63InterventionalTreatment
AbbVie
~200 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Upadacitinib 15mg DoseDupilumab 300mg DoseUpadacitinib 30mg Dose

At a glance

Recruiting sites
109 of 128 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90)
Measured over At Week 8

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

128 sites across 52 states
Florida21
Texas13
California11
Puerto Rico6
Spain5
Georgia3
Massachusetts3
Michigan3

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

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 and for the duration of the study. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening visit.

Exclusion

Meeting any of the following conditions at Baseline:
Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions;
Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
One or more past episodes of disseminated herpes simplex (including eczema herpeticum);
HIV infection defined as confirmed positive anti- HIV Ab test;
Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV);
Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
For Japan: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;
Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.
At Baseline any of the following medical diseases or disorders:
Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;
Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol;
Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomization;
History of an organ transplant which requires continued immunosuppression;
History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding/segmentation are not excluded;
History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.

What this trial measures

  • Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90)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.