jRCT2041240157招募中不适用
A multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial to evaluate safety and efficacy of spesolimab (BI 655130) in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy (A study to test whether spesolimab helps people with a skin condition called pyoderma gangrenosum)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 主要终点
- PGAR-100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adult trial participants, aged >=18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
- •Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- •A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (>= 10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.
- •At least one measurable (defined as measuring >= 5 cm2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.
- •At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers > 6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
- •Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the protocol.
排除标准
- •Trial participants with non-PG lesions.
- •Trial participants with a target PG ulcer measuring >80 cm
- •Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
- •Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.
- •Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed >=2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit
- •"Active or latent tuberculosis (TB)
- •Participants with active TB are excluded
- •Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial."
- •Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
- •Severe, progressive, or uncontrolled hepatic disease, defined as >3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or >2x ULN elevation in total bilirubin
结局指标
主要结局
PGAR-100
时间窗: up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Achievement of complete closure (100% pyoderma gangrenosum area reduction) of the target PG ulcer
次要结局
- Achievement of PGAR-100 of the target PG ulcer at Week 26(Week 26)
- Achievement of PGAR-100 of any measurable PG ulcer (5 cm2 or larger at baseline) at any time up to Week 26(Up to Week 26)
- Achievement of PGAR-100 of all measurable PG ulcers (5 cm2 or larger at baseline) at any time up to Week 26(Up to Week 26)
- Achievement of 3-point or more reduction in NRS (Numeric Rating Scale) Pain score from baseline at Week 4(Week 4)
- Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52(Week 26 up to Week 52)
研究者
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