A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa - NOVA

Janssen-Cilag International NV0 个研究点目标入组 180 人开始时间: 2018年8月27日最近更新: 2020年11月23日

试验速览

暂无简介。

•- Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
•-Have moderate to severe HS for at least 1 year (365 days) prior to the baseline visit.
•-Have HS lesions present in at least 2 distinct anatomic areas.
•-Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
•-Have stable HS for at least 1 month (28 days) prior to the screening visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 162
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•-Any other active skin disease or condition that could have interfered with assessment of HS.
•-Has a draining fistula count of >20 at the baseline visit.
•-Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
•-Receipt of systemic non-biologic therapies for the treatment of HS <4 weeks prior to the baseline visit.
•-Receipt of immunomodulatory biologic therapies (eg monoclonal antibodies) within 3 months or 5 half-lives prior to the baseline visit, whichever is longer.
•-Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 weeks prior to the baseline visit.

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