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 - CCFZ533H12201BC

ovartis Pharma AG0 个研究点目标入组 348 人开始时间: 2024年4月4日最近更新: 2024年7月22日

适应症

试验速览

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•Male and female patients, 18 to 65 years of age (inclusive), with clinically diagnosed HS for at least 12 months prior to Screening., For Cohort A (iscalimab), C (MAS825) and E (VAY736): A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules., For Cohort B (LYS006) and D (LOU064): A total of at least 3 inflammatory lesions, i.e., abscesses and/or inflammatory nodules., For all Cohorts: No more than 15 fistulae and at least two anatomical areas need to be involved with HS lesions.

•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., Use/receipt of some specific treatments during specified time frames, depending on the cohort., WoCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for the subsequent 14 weeks after the last study drug administration for Cohort A (iscalimab) and the subsequent 2 weeks after the last study drug administration for Cohort B (LYS006) and D (remibrutinib). In Cohort C, WoCBP will be asked to adhere to highly effective contraception from at least 3 months prior to first drug administration and until 5 months after the final dose (Day 225 to Day 253), when a pregnancy test will be conducted. In Cohort E, WoCBP will be required to adhere to highly effective contraception for 6 months after the final dose (Day 253 to Day 281).

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