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Evaluating Upadacitinib for Adults with Severe Atopic Dermatitis Not Responding to Dupilumab

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Phase 3 Interventional AbbVie · NCT06389136

This study is testing if upadacitinib can help adults with severe atopic dermatitis who haven't improved with dupilumab to see if it works better for them.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 63 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsdupilumab, upadacitinib
Locations126 sites (Birmingham, Alabama and 125 other locations)
Trial IDNCT06389136 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of upadacitinib, an approved treatment for moderate to severe atopic dermatitis, in adults who have not adequately responded to dupilumab. Participants are randomly assigned to receive either upadacitinib or dupilumab, with the possibility of dose adjustments based on their response. The study is conducted in two periods, allowing for reassessment and potential dose changes based on the severity of their condition as measured by the Eczema Area and Severity Index. The goal is to determine the most effective dosing strategy for managing atopic dermatitis in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe atopic dermatitis who have shown inadequate response to dupilumab after at least four months of treatment.

Not a fit: Patients who have not previously used dupilumab or those with mild atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with severe atopic dermatitis who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 125 other locations

+76 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisUpadacitinibRinvoqABT-494
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.