EUCTR2018-002757-30-DK进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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) and C (MAS825): 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.
- •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 197
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •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.
- •2. Use/receipt of some specific treatments during specified time frames
- •3. 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 cohort D (LOU064). In Cohort C (MAS825), 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.
- •Other protocol-defined exclusion criteria may apply
研究者
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