[M23-698] 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

Yamazaki Hayato0 个研究点目标入组 1,328 人开始时间: 2023年6月27日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Minimum Age:12 Years
•-Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e.through medical history and interview of subject).
•-Documented history of previous use of or higher 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
•-Participant must have a total AN count of or higher 5 at Baseline.
•-HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
•-At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
•-Draining fistula count of or lower 20 at Baseline.

•-History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
•-Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
•-Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
•-Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
•-Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.

发起方

Yamazaki Hayato