Acne Inversa / Hidradenitis Suppurativa: Assessment of Upadacitinib in Adult and Adolescent Patients
Descrizione riassuntiva dello studio
Acne inversa (AI) is an inflammatory skin disease that causes painful lesions in the armpits, groin area, and anal/genital region. This study assesses the safety and efficacy of Upadacitinib in treating adult and adolescent study participants with moderate to severe AI who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. Adverse events and changes in disease activity will be assessed. Upadacitinib is an approved medication for the treatment of ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, and is being developed for the treatment of AI. This study is double-blind, meaning that neither the study participants nor the study physicians know whether a participant is receiving Upadacitinib or placebo. This study consists of three phases. In Phase 1, participants are randomized into two so-called treatment arms, with participants in each treatment arm receiving a different treatment. There is a 50% chance that study participants will be assigned to placebo. In Phase 2, participants are divided into six different groups based on their assignment and the results from Phase 1. Phase 3 is the long-term continuation phase, where participants continue the treatment from Phase 2. Approximately 1,328 adult and adolescent patients with AI diagnosis will be enrolled at approximately 275 study centers worldwide.
(BASEC)
Intervento studiato
In Phase 1 and Phase 2, participants receive Upadacitinib or placebo as a tablet taken once daily for 36 weeks. Eligible participants from Phase 1 and Phase 2 will participate in Phase 3 and receive Upadacitinib or placebo as a tablet taken once daily for 68 weeks. Participants will be followed for approximately 30 days.
(BASEC)
Malattie studiate
Acne Inversa (AI) / Hidradenitis Suppurativa (HS)
(BASEC)
- 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)
Criteri di esclusione
- 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)
Luogo dello studio
Berna, Ginevra, San Gallo, Zurigo
(BASEC)
Sponsor
AbbVie Inc. North Chicago USA AbbVie AG Cham CH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
12.12.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (BASEC)
Titolo accademico
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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