NCT07444684尚未招募2 期
A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The proportion of participants who achieved PGAR-100 in the target PG ulcer at any time before Week 26, with confirmation at the next consecutive study visit (at least 2 weeks later).
研究概览
简要总结
This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged ≥18 years at the time of signing the informed consent form, regardless of gender;
- •Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;
- •At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);
- •The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- •Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm/egg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.
排除标准
- •Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;
- •The measured area of the target PG ulcer exceeding 80 cm² at screening;
- •Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;
- •Participants with active infection in the PG ulcer(s) at screening;
- •A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
- •A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;
- •Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.
研究组 & 干预措施
SHR-1139 Injection Group
Experimental
干预措施: SHR-1139 Injection (Drug)
结局指标
主要结局
The proportion of participants who achieved PGAR-100 in the target PG ulcer at any time before Week 26, with confirmation at the next consecutive study visit (at least 2 weeks later).
时间窗: At any time before Week 26.
PGAR-100: 100% reduction in pyoderma gangrenosum (PG) ulcer area, i.e., complete ulcer closure.
次要结局
- The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26.(Up to 64 weeks.)
- The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26.(At any time before Week 26.)
- The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26.(At any time before Week 26.)
- The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26.(At any time before Week 26.)
研究者
研究点 (1)
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