Acne Inversa / Hidradenitis Suppurativa: Assessment of Upadacitinib in Adult and Adolescent Patients

Kriterien zur Teilnahme
- AI diagnosis at least 6 months prior to baseline as assessed by the investigator (i.e., based on medical history and questioning of the study participant) - Documented prior use of a TNF inhibitor for the treatment of AI for at least 12 weeks and/or an approved biologic therapy without anti-TNF agent for the treatment of AI for at least 16 weeks, to which they did not adequately respond or for which, in the investigator's assessment, there was an intolerance at any time - The study participant must have a total of 5 abscesses and inflammatory nodules at baseline; AI lesions must be present at baseline in at least two different anatomical areas - At least one anatomical area affected by AI, classified as Hurley Stage II or higher at baseline - Number of draining fistulas of 20 at baseline (BASEC)

Ausschlusskriterien
- Active skin disease other than AI that could affect the assessment of AI, including skin infections (bacterial, fungal, or viral) that required treatment with systemic therapy within four weeks prior to the baseline visit - Treatment with a study drug (biologic or chemical) within at least 30 days or 5 half-lives of the drug (whichever is longer) prior to the first administration of the study drug or current participation in another clinical study. The use of other study drugs is also not allowed during the study. - Prior treatment with a cell-depleting therapy, including an anti-CD20 antibody (e.g., Rituximab), within 12 months prior to baseline or until the number of B cells returns to normal or to the pre-treatment value - Use of prescription topical therapies (including topical antibiotics) that may also be used for the treatment of AI within 14 days prior to the baseline visit - Use of systemic (including oral) antibiotics for the treatment of AI or another chronic inflammatory disease within 14 days prior to the baseline visit (BASEC)