A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa - Efficacy and safety of different investigational drugs for the treatment of hidradenitis suppurativa

ovartis Pharma AG0 个研究点目标入组 90 人开始时间: 2019年1月28日最近更新: 2024年5月21日

研究概览

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•- Male or female, age 18-65 years, at least 50 kg body weight with moderate to severe HS
•- Clinically diagnosed HS for at least 12 months prior to screening
•- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
•- For Cohort B (LYS006): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas involved with HS lesions
•Other protocol-defined inclusion criteria may apply
•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 89
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or
•longer if required by local regulations
•- Women of childbearing potential, unless they are using highly effective methods of contraception during dosing and for a minimum of 12 weeks after stopping medication for cohort A (iscalimab) and a minimum of 2 weeks after the last study drug administration for cohort B (LYS006).
•- Pregnant or nursing (lactating) women
•Other protocol-defined exclusion criteria may apply

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