UPADACITINIB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- - Participant meets all the following disease activity criteria at Baseline Visit:\n- • Eczema Area and Severity Index (EASI) score >= 12;\n- • Validated Investigator´s Global Assessment for AD (vIGA-AD) score >= 3;\n- • Body surface area (BSA) involvement of >= 10% in a majority of subjects (>= 50% of the overall study population)\n- • 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.\n- • Inadequate response to dupilumab treatment after at least 4 months of current use.\n- • 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.\n- • Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria."}

Exclusion criteria

• {"criterion_text":"- Meeting any of the following conditions at Baseline:\n- • Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV)\n- • At Baseline any of the following medical diseases or disorders:\n- • Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;\n- • Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol;\n- • 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;\n- • History of an organ transplant which requires continued immunosuppression;\n- • 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;\n- • History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;\n- • 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;\n- • History of malignancy except for successfully treated or localized carcinoma in situ of the cervix\n- • 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;\n- • Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;\n- • One or more past episodes of disseminated herpes simplex (including eczema herpeticum);\n- • HIV infection defined as confirmed positive anti- HIV Ab test;\n- • Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);\n- • 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;\n- • 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;\n- • 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."}

Primary endpoints

• {"endpoint_text":"- Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) at Week 8","definition_or_measurement_approach":"Measured as at least a 90% reduction in Eczema Area and Severity Index from baseline (EASI 90) assessed at Week 8."}

Secondary endpoints

• {"endpoint_text":"- Percentage of participants who achieve a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 8","definition_or_measurement_approach":"Measured as proportion of participants with WP-NRS score of 0 or 1 at Week 8."}
• {"endpoint_text":"- Participants who simultaneous achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 8","definition_or_measurement_approach":"Composite responder defined as achieving both EASI 90 and WP-NRS 0/1 at Week 8."}
• {"endpoint_text":"- Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 at Week 4","definition_or_measurement_approach":"Measured as proportion of participants with WP-NRS score of 0 or 1 at Week 4."}

Methods

• Recruitment materials: adverts, recruitment brochures and recruitment flyers (documents titled 'Ad and Recruitment_Recruitment Brochure' and 'Recruitment Flyer' are listed for multiple countries).
• Third-party agencies contracted for patient recruitment and retention (Clinical Trial Media Inc. listed with duty 'Patient Recruitment and Retention'; WCG Clinical Inc. listed with duties including 'Patient Recruitment').
• Country-specific recruitment arrangements and ICF procedures documents available for Romania, Spain and Italy (K1/K2/I CF documents listed).

Spain

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

62

Number Of Sites

5

Number Of Participants

24

Italy

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

18-02-2026

Processing Time Days

35

Number Of Sites

4

Number Of Participants

14

Romania

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

20

Number Of Sites

4

Number Of Participants

12

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

IQVIA Limited

Responsibilities

code:3

Name

WCG Clinical Inc.

Responsibilities

Patient Recruitment; Web Based Training; Adjudication Committee

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment and Retention; code:2","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment; Web Based Training; Cardiovascular and Gastrointestinal Perforation Adjudication Committee","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA/ ePRO","organisation_type":"Non-Pharmaceutical company"}