NCT05964413终止3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- InflaRx GmbH
- 入组人数
- 54
- 试验地点
- 50
- 主要终点
- Efficacy of treatment with vilobelimab compared to placebo
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum
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
- •18 years or older at the time of signing the informed consent.
- •Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer, Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case of PARACELSUS score < 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative PG.
- •Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline
- •circulated by intact skin
- •evaluable by at least 2-dimensional measurement
排除标准
- •Patients with target ulcers exceeding 80 cm 2 .
- •Patients with target ulcer in transplanted skin.
- •Surgical wound debridement or negative pressure wound therapy (NPWT) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).
- •Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
- •Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- •Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- •Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
- •Patients received any biological or immunomodulatory therapy for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP), except existing biologic or immunomodulatory therapy used for an underlying disease (other than PG at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued.
- •Patients receiving corticosteroids treatment for PG of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with IMP).
研究组 & 干预措施
vilobelimab
Experimental
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
干预措施: vilobelimab (Drug)
Placebo
Placebo Comparator
Patients will receive placebo IV in the same schedule as patients in Arm 1
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of treatment with vilobelimab compared to placebo
时间窗: Week 1 to Week 26
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
次要结局
- Efficacy of treatment with vilobelimab compared to placebo(2 weeks between study visits)
- Pain reduction(Week 10 through study completion)
研究者
研究点 (50)
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