A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 44
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history
- •Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold)
- •Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigator's opinion
- •Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 3 at the screening and baseline visit
- •Must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath
排除标准
- •Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS
- •Has a draining fistula count of greater than (>) 20 at the baseline visit
- •Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit
- •Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4 Weeks prior to the baseline visit
- •Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit
研究组 & 干预措施
Group 1: Guselkumab Regimen 1
Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
干预措施: Placebo (Drug)
Group 1: Guselkumab Regimen 1
Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
干预措施: Guselkumab dose 1 (Drug)
Group 1: Guselkumab Regimen 1
Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
干预措施: Guselkumab dose 2 (Drug)
Group 2: Guselkumab Regimen 2
Participants will receive guselkumab dose 2 subcutaneously.
干预措施: Guselkumab dose 2 (Drug)
Group 2: Guselkumab Regimen 2
Participants will receive guselkumab dose 2 subcutaneously.
干预措施: Placebo (Drug)
Group 3: Placebo then Guselkumab
Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC.
干预措施: Guselkumab dose 2 (Drug)
Group 3: Placebo then Guselkumab
Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC.
干预措施: Guselkumab dose 3 (Drug)
Group 3: Placebo then Guselkumab
Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
时间窗: Week 16
HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
次要结局
- Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16(Week 16)
- Change From Baseline in the Number of Abscesses at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0(Week 16)
- Change From Baseline in HSSD Symptom Scale Total Score at Week 16(Baseline and Week 16)
- Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16(Baseline and Week 16)
- Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline(Week 16)
- Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16(Baseline and Week 16)
- Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16(Week 16)
- Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16(Week 16)
- Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16(Week 16)
- Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0(Week 16)
- Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0(Week 16)
- Change From Baseline in Number of Draining Fistulas at Week 16(Baseline and Week 16)
- Change From Baseline in Number of Inflammatory Nodules at Week 16(Baseline and Week 16)
- Percentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16(Week 16)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16(Baseline and Week 16)
- Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16(Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16(Week 16)