A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
研究概览
简要总结
Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa.
The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks.
Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks.
Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- •At least 18 years of age
- •Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
- •HS lesions are present in at least 2 distinct anatomic areas
- •Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
- •Must have at least 5 inflammatory nodules or abscesses at screening
- •Use adequate birth control for subject and partners of child bearing potential
- •Willing and able to give written Informed Consent
排除标准
- •Pregnant or breast-feeding
- •Any other skin disease that may interfere with the assessment of HS
- •Rapidly progressive, expanding HS within 30 days prior to screening
- •More than 20 draining fistulae at screening
- •Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment
- •Systemic antibiotics are generally excluded
- •Topical antibiotics use within 14 days prior to Day 1 is excluded
- •Have started a topical prescription medicine for HS within 14 days prior to screening
- •A systemic medicine for HS, including biologics and other systemic therapies
- •Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason
研究组 & 干预措施
Placebo to Avacopan 10 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
干预措施: Avacopan (Drug)
Group A
Placebo twice daily (BID) for Period 1 of the study
干预措施: Placebo (Other)
Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
干预措施: Avacopan (Drug)
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
干预措施: Avacopan (Drug)
Placebo to Avacopan 30 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
干预措施: Avacopan (Drug)
结局指标
主要结局
Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
时间窗: Baseline to Week 12
The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.
次要结局
- Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12(Baseline to Week 12)
- Change From Baseline in Inflammatory Nodule Count at Week 12(Baseline and Week 12)
- Change From Baseline in Total AN Count at Week 12(Baseline to Week 12)
- Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1(Day 1)
- Change From Baseline in Abscess Count at Week 12(Baseline and Week 12)
- Change From Baseline in Draining Fistula Count at Week 12(Baseline and Week 2, Week 4, Week 8 and Week 12)
- Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12(Baseline and Week 12)
- Change of IHS4 Score Relative to Baseline at Week 12.(Baseline and Week 12)
- Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS(Baseline and Week 2, Week 4, Week 8 and Week 12)