A Phase 2 Multicenter, Investigator-blind, Subject-blind, Placebo-controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects with Moderate to Severe Hidradenitis Suppurativa

CB Biopharma SPR0 个研究点目标入组 160 人开始时间: 2017年7月27日最近更新: 2019年12月10日

研究概览

暂无简介。

•- Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
•1 year prior to Baseline
•- Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
•- Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
•- Total abscess and inflammatory nodule count >=3 at the Baseline Visit
•- Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified
•over-the-counter topical antiseptics on their HS lesions
•- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must
•be willing to use a highly effective method of contraception up till 20 weeks after last administration of
•study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
•- Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks
•after the last administration of study medication
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Prior treatment with anti-IL17s or participation in an anti-IL17 study
•- Previously received anti-TNFs
•- Subject requires, or is expected to require, opioid analgesics for any reason (excluding
•- Subject received prescription topical therapies for the treatment of HS within 14 days prior to
•the Baseline Visit
•- Subject received systemic non-biologic therapies for HS with potential therapeutic impact for
•HS less than 28 days prior to Baseline Visit
•- Draining fistula count >20 at the Baseline Visit
•- Diagnosis of inflammatory conditions other than HS

发起方

CB Biopharma SPR