A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Suppurativa

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 190 人开始时间: 2019年7月25日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Subjects must be = 18 years old at Screening with a clinical diagnosis of moderate to severe HS (defined as a total AN count of = 5 at Baseline, presence of HS lesions in at least 2 distinct anatomic areas, and draining fistula count of = 20 at Baseline) for at least 1 year prior to Baseline, as determined by the investigator (i.e., through medical history, interview of subject).
•Subjects must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
•Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the study population)
•Prior exposure to anti-TNF (overall, no more than 15% of the study population)
•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 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•No history of active skin disease other than HS that could interfere with the assessment of HS.
•No active TB or concurrent treatment for latent TB and no evidence of HBV, HCV or HIV.
•No documented active or suspected malignancy or history of any malignancy within the last 5 years.
•No history of organ transplantation.
•No exposure to other immunomodulatory biologic therapies, including anti-IL-1 within 3 months or 5 half-lives, whichever is longer, prior to Baseline.
•No previous treatment with any cell-depleting therapies including but not limited to anti-CD20 within 12 months prior to Baseline or until B cell count returns to normal level.

发起方