A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT05507580
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to<br> Baseline and participant meets Hanifin and Rajka criteria.<br><br> - Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10%<br> Body Surface Area (BSA) of AD involvement at the Baseline Visit.<br><br> - Baseline weekly average of daily Worst Pruritus NRS >= 4.<br><br> - Candidate for systemic treatment defined as prior use of systemic treatment for AD,<br> OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical<br> treatments are otherwise medically inadvisable.<br><br>Exclusion Criteria:<br><br> - Participants with current or past history of infection including:<br><br> - Two or more episodes of herpes zoster, or one or more episodes of disseminated<br> herpes zoster;<br><br> - One or more episodes of disseminated herpes simplex (including eczema<br> herpeticum);<br><br> - Human immunodeficiency virus (HIV) infection defined as confirmed positive<br> anti-HIV antibody (HIV Ab) test;<br><br> - Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified<br> requirements for TB testing);<br><br> - Japan only: Positive result of beta-D-glucan (screening for Pneumocystis<br> jirovecii infection) or two consecutive indeterminate results of beta-D-glucan<br> during the Screening Period;<br><br> - Active infection(s) requiring treatment with intravenous anti-infectives within<br> 30 days, or oral/intramuscular anti-infectives within 14 days prior to the<br> Baseline Visit;<br><br> - Chronic recurring infection and/or active viral infection that, based on the<br> investigator's clinical assessment, makes the participant an unsuitable<br> candidate for the study;<br><br> - COVID-19 infection: In participants who tested positive for COVID, at least 5<br> days must have passed since a COVID-19 positive test result for study entry of<br> asymptomatic participants. Participants with mild/moderate COVID-19 infection<br> can be enrolled if fever is resolved without use of antipyretics for 24 hours<br> and other symptoms improved, or if 5 days have passed since the COVID-19<br> positive test result (whichever comes last). Participants may be rescreened if<br> judged to be in good general health, as determined by the investigator based<br> upon the medical history and physical examination.<br><br> - Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).<br><br> - Any of the following medical diseases or disorders:<br><br> - Recent (within past 6 months) cerebrovascular accident, myocardial infarction,<br> coronary stenting, and aorto-coronary bypass surgery;<br><br> - History of an organ transplant which requires continued immunosuppression;<br><br> - History of an allergic reaction or significant sensitivity to constituents of<br> the study drug (and its excipients) and/or other products in the same class;<br><br> - History of gastrointestinal perforation (other than due to appendicitis or<br> mechanical injury), diverticulitis, or significantly increased risk for<br> gastrointestinal perforation per investigator judgment;<br><br> - Conditions that could interfere with drug absorption including but not limited<br> to short bowel syndrome or gastric bypass surgery; participants with a history<br> of gastric banding/segmentation are not excluded;<br><br> - History of malignancy except for successfully treated non-melanoma skin cancer<br> (NMSC) or localized carcinoma in situ of the cervix.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving EASI 75;Percentage of Participants Achieving EASI 100;Percentage of Participants Achieving EASI 75;Percentage of Participants Achieving EASI 90;Percentage of Participants Achieving EASI 100;Percentage of Participants Achieving EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1;Percentage of Participants Achieving EASI 90 and Worst Pruritus NRS of 0 or 1;Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1;Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4;Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1;Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4;Percentage of Participants Achieving DLQI of 0 or 1