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

Launched by ABBVIE · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called upadacitinib for adults with moderate to severe atopic dermatitis (AD), a skin condition that causes rashes and itching. The trial aims to find out how well different doses of upadacitinib work and how safe they are for people who haven’t had enough relief from another treatment called dupilumab. About 300 adults aged 18 to 64 who have used dupilumab for at least four months but still struggle with their skin condition can participate in this study. To join, participants must meet specific criteria, including having a certain level of skin severity and itchiness at the start of the trial.

Participants in the trial will be assigned to receive either upadacitinib or dupilumab for about 32 weeks, with regular check-ups to monitor their progress and any side effects. They will attend visits at a hospital or clinic where they will undergo medical assessments, blood tests, and complete questionnaires. It’s important to note that the treatment may involve more visits and monitoring than their usual care. This study is currently recruiting participants at various sites around the world.

Gender

ALL

Eligibility criteria

• Inclusion 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;
• • 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.
• • 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, (note: include the following only for new protocols) 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; subjects with a history of gastric banding/segmentation are not excluded;
• • History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;