A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 154
- 试验地点
- 26
- 主要终点
- Percentage of Participants Achieving Clinical Response at Week 16
研究概览
简要总结
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
详细描述
This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I [abscess formation without scarring and sinus tracts], II [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple interconnected abscesses and sinus tracts across entire area]. Randomization in this study was performed using stratification by Hurley Stage [III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with stable, moderate to severe hidradenitis suppurativa
- •Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
- •Ability to administer subcutaneous injections
- •General good health otherwise
排除标准
- •Prior anti-TNF therapy
- •Unstable antibiotic therapy for HS
- •Required medication washouts for other HS treatments
- •Prior exposure to Tysabri® (natalizumab);
- •Recent infection requiring treatment
- •Significant medical events or conditions that may put patients at risk for participation
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- •History of cancer, except successfully treated skin cancer
- •Recent history of drug or alcohol abuse
研究组 & 干预措施
Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
干预措施: Placebo (Drug)
Adalimumab 40 mg qwk
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
干预措施: adalimumab (Biological)
Adalimumab 40 mg eow
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
干预措施: adalimumab (Biological)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response at Week 16
时间窗: Baseline, Week 16
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
次要结局
- Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Clinical Response at Week 2(Baseline, Week 2)
- Percentage of Participants Achieving Clinical Response at Week 4(Baseline, Week 4)
- Percentage of Participants Achieving Clinical Response at Week 8(Baseline, Week 8)
- Percentage of Participants Achieving Clinical Response at Week 12(Baseline, Week 12)
- Change From Baseline in Modified Sartorius Scale at Week 16(Baseline, Week 16)
- Change From Baseline in Modified Sartorius Scale at Week 52(Baseline, Week 52)
- Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52(Baseline, Week 52)