Last updated 10 days ago
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
300 patients around the world
Available in Puerto Rico, Colombia, United States
AbbVie
6Research sites
300Patients around the world
This study is for people with
Dermatitis
Atopic dermatitis
Requirements for the patient
To 63 Years
All Gender
Medical requirements
- 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.
- 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.Active TB or meet TB exclusionary parameters.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.Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.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.History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
Sites
Centro Integral de Reumatología del Caribe Circaribe SAS
Recruiting
Clínica de Inmunología y Genética - CIGE
Recruiting
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas) - Bogotá
Recruiting
Clinical Research Puerto Rico
Recruiting
GCM Medical Group - Puerto Rico
Recruiting
Caribbean Medical Research Center
Recruiting
StudySwitch-Up
SponsorAbbVie
Study typeInterventional
Conditions
Atopic dermatitis
Requirements
To 63 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06389136
