NCT07765628尚未招募2 期
A Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HS-20118 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 120 人开始时间: 2026年8月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.
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
- Triple (Participant, Care Provider, 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
- •Participants voluntarily agree to comply with all study procedures and scheduled follow-up assessments, and to cooperate with the collection of lesion photographs and other protocol-specified requirements;
- •Diagnosis of plaque psoriasis, with or without PsA, established for at least 26 weeks prior to the first administration of study intervention. If previously diagnosed with psoriasis, participants must have a documented history of psoriasis for at least 26 weeks and must be confirmed by the investigator during screening to have plaque psoriasis;
- •At screening and baseline, participants must be confirmed by the investigator to have stable moderate-to-severe plaque psoriasis, as defined by meeting all of the following four criteria:
- •1) No morphological changes or significant disease flares during the 4 weeks preceding screening, as assessed by the investigator; 2) BSA≥10%； 3) PASI≥12； 4) IGA≥3；
- •Be a candidate for phototherapy or systemic treatment for plaque psoriasis;
- •Participants must have no plans for pregnancy or sperm/egg donation during the study period. If of childbearing age, women must not be pregnant or breastfeeding, and must have a negative blood pregnancy test within 7 days before randomization. Participants and their partners must voluntarily use highly effective contraception during the study period and for at least 3 months after the last dose.
排除标准
- •Known allergy, hypersensitivity, or intolerance to biologics, study drugs, or their excipients.
- •Non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) at screening or randomization.
- •Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
- •Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
- •Severe, progressive, or poorly controlled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematologic, rheumatologic, psychiatric, or metabolic disorders; or current signs or symptoms related to these conditions.
- •History of malignancy within 5 years before screening (except for adequately treated skin basal cell carcinoma, in situ skin cancer, or in situ cervical cancer with no recurrence for at least 12 weeks before the first dose).
- •History of lymphoproliferative disorders (e.g., lymphoma), unexplained monoclonal gammopathy, or signs and symptoms suggestive of lymphoproliferative disorders (e.g., splenomegaly or severe lymphadenopathy).
- •Any other condition deemed by the investigator as unsuitable for participation in the clinical study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HS-20118 dose 1
Experimental
干预措施: HS-20118 (Drug)
HS-20118 dose 2
Experimental
干预措施: HS-20118 (Drug)
结局指标
主要结局
Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16
时间窗: 16 weeks
Percentage of participants achieving PASI 75 response (\>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
次要结局
未报告次要终点
研究者
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