NCT07265284招募中3 期
A Phase Ⅰ/Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年12月3日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and/or systemic treatment for psoriasis.
排除标准
- •History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent Hsa received IBI112
研究组 & 干预措施
placebo
Placebo Comparator
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44
干预措施: placebo (Drug)
IBI112
Experimental
Participants receive IBI112 through week 44
干预措施: IBI112 (Drug)
结局指标
主要结局
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
时间窗: week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
次要结局
- Percentage of patients achieving PASI 90 at week 16(week 16)
- Percentage of patients achieving PASI 50 at week 16(week 16)
- Percentage of patients achieving an sPGA 0 at week 16(week 16)
- Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16(week 16)
- Percentage of patients achieving PASI 75 at week 56(week 56)
- Percentage of patients achieving PASI 90 at week 56(week 56)
- Percentage of patients achieving PASI 100 at week 56(week 56)
- Percentage of patients achieving PASI 100 at week 16(week 16)
- Percentage of patients achieving an sPGA 0/1 at Week 56(week 56)
- Percentage of patients achieving an sPGA 0 at Week 56(week 56)
研究者
研究点 (1)
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