A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 177
- 主要终点
- Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio.
The study will comprise:
- A Screening Period which will last up to 28 days.
- A Treatment Period up to 16 weeks.
- A Follow-up period of 6 weeks after the last dose of study drug.
The maximum clinical trial duration for each participant is 24 weeks.
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
- •Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
- •At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.
排除标准
- •Has a draining fistula count of ≥
- •Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS.
- •History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS).
- •Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.
研究组 & 干预措施
Placebo
Patients will receive matching placebo.
干预措施: Placebo (Drug)
AVTX-009 Regimen 1
Patients will receive AVTX-009 regimen 1.
干预措施: AVTX-009 Regimen 1 (Drug)
AVTX-009 Regimen 2
Patients will receive AVTX-009 regimen 2.
干预措施: AVTX-009 Regimen 2 (Drug)
结局指标
主要结局
Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
时间窗: At Week 16
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.
次要结局
- Proportion of patients achieving HiSCR50(At Week 16)
- Proportion of patients achieving HiSCR90(At Week 16)
- Change from Baseline in International HS Severity Score System (IHS4)(Baseline (Day 1) and Week 16)
- Change from Baseline in total abscess and inflammatory nodule (AN) count(Baseline (Day 1) and Week 16)
- Change from Baseline in draining fistula count(Baseline (Day 1) and Week 16)
- Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from Baseline on a Numerical Rating Scale (NRS) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 (NRS30)(Baseline (Day 1) and Week 16)
- Percentage of patients with flares(From Baseline (Day 1) to Week 16)
- AVTX-009 anti-drug antibodies (ADA)(From Baseline (Day 1) to Week 20)
- Safety and tolerability of AVTX-009(From Baseline (Day 1) to Week 20)