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A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab ( Switch-Up )
EU CTIS ID: 2025-523347-35-00
What this study is testing
To assess the efficacy and safety of upadacitinib compared with dupilumab as per its label, in adult subjects with inadequate response to dupilumab.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- Meeting any of the following conditions at Baseline:
- • Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- 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;
See the full eligibility criteria
Who can join
- - 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.
- • Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.
What rules you out
- Meeting any of the following conditions at Baseline:
- • Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- 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 or localized carcinoma in situ of the cervix
- • 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;
- • Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
- • 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.
The study team makes the final eligibility decision.
Where it's taking place
- Puerto Rico
- United States
- Canada
- Korea, Republic of
- Colombia
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Puerto Rico; United States; Canada; Korea, Republic of; Colombia; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.