A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
研究概览
简要总结
The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.
详细描述
Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
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
- •Male or female, ≥ 18 years of age
- •Written informed consent obtained from subject
- •Diagnosis of HS for at least 1 year
- •Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of which must be at least Hurley Stage II or Stage III
- •Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics
- •Total abscess and inflammatory nodule (AN) count of ≥ 3
排除标准
- •Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening
- •Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline only) who have not been on a stable dose during the 28 days before Screening
- •Subject received systemic non-biologic therapy for HS with potential therapeutic impact for HS during the 28 days before Screening (other than permitted oral antibiotics)
- •Prior treatment with any of the following medications during the 28 days before Screening:
- •Any other systemic therapy for HS
- •Any iv anti-infective therapy
- •Phototherapy (ultraviolet B or psoralen and ultraviolet A)
- •History of heart disease or malignancy
研究组 & 干预措施
Cohort 1
Placebo
干预措施: Placebo (Drug)
Cohort 2
Minimum Dose IFX-1 (400 mg Q4W)
干预措施: IFX-1 (Drug)
Cohort 3
Low dose IFX-1 (800 mg Q4W)
干预措施: IFX-1 (Drug)
Cohort 4
Medium Dose IFX-1 (800 mg Q2W)
干预措施: IFX-1 (Drug)
Cohort 5
High Dose IFX-1 (1200 mg Q2W)
干预措施: IFX-1 (Drug)
结局指标
主要结局
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
时间窗: Week 16
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
次要结局
- Absolute Change in Modified Sartorius Score (mSS) From Day 1.(From Day 1 until Day 309)
- Percentage of Patients Achieving NRS50.(From Day 1 until Day 309)
- Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.(From Day 1 until Day 309)
- Safety Parameters (Adverse Events) Will be Assessed.(From Day 1 until Day 309)
- Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12(Week 12)
- Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.(From Day 1 until Day 309)
- Percentage of Patients Achieving NRS30(From Day 1 until Day 309)
- Number of Patients With Flares Relative to Day 1(From Day 1 until Day 309)