A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 55
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
研究概览
简要总结
The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.
详细描述
This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.
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
- •Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit
- •Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus
- •either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
- •with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III
- •Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites
- •The HS surgical site must contain at least one active HS lesion
- •The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon
排除标准
- •Participant has a draining fistula count of greater than 20 at the Baseline visit
- •Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
- •Participant requires surgical management prior to Week 13
- •Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant
研究组 & 干预措施
Placebo
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
干预措施: Placebo (Drug)
Adalimumab
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
时间窗: At Week 12
HiSCR is defined as at least a 50% reduction in the 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
- Percentage of Participants Achieving HiSCR-es at Week 12(At Week12)
- Percentage of Participants Achieving HiSCR-es at Week 24(At Week 24)
- Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12(From Baseline to Week 12)
- Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery(At Week 12)