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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 248
- 试验地点
- 36
- 主要终点
- Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR)
研究概览
简要总结
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
详细描述
This is a randomized, subject and investigator-blinded, placebo-controlled, multi-center and parallel-group non-confirmatory study to assess the efficacy, safety and tolerability of five investigational drugs, CFZ533 (iscalimab), LYS006, MAS825, LOU064 (remibrutinib) and VAY736 (ianalumab) in subjects with moderate to severe hidradenitis suppurativa.
All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period.
All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
- •Minimal body weight of 50 kg
- •Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule
排除标准
- •Use of other investigational drugs at the time of screening or before
- •Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- •Pregnant or lactating women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Cohort A - CFZ533 600 mg
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
干预措施: CFZ533 (Drug)
Cohort B - LYS006 20 mg
LYS006 20 mg administered orally twice per day until Week 16.
干预措施: LYS006 (Drug)
Cohort A - Placebo to CFZ533
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
干预措施: Placebo to CFZ533 (Drug)
Cohort C - MAS825 300 mg
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
干预措施: MAS825 (Drug)
Cohort B - Placebo to LYS006
Placebo administered orally twice per day until Week 16.
干预措施: Placebo to LYS006 (Drug)
Cohort C - Placebo to MAS825
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
干预措施: Placebo to MAS825 (Drug)
Cohort D - LOU064 25mg
LOU064 25 mg administered orally twice per day until Week 16.
干预措施: LOU064 25mg (Drug)
Cohort D - LOU064 100mg
LOU064 100 mg administered orally twice per day until Week 16.
干预措施: LOU064 100mg (Drug)
Cohort D - Placebo to LOU064
Placebo administered orally twice per day until Week 16.
干预措施: Placebo to LOU064 (Drug)
Cohort E - VAY736 300 mg
VAY736 300 mg administered s.c every 4 weeks until Week 13.
干预措施: VAY736 (Drug)
Cohort E - Placebo to VAY736
Placebo administered s.c every 4 weeks until Week 13.
干预措施: Placebo to VAY736 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR)
时间窗: Baseline, Week 16
sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included.
次要结局
未报告次要终点