2024-515706-77-00招募中3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 399
- 试验地点
- 78
- 主要终点
- IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16.
研究概览
简要总结
To evaluate the efficacy of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •1.≥12 years of age at the screening visit.
- •Diagnosis of moderate to severe plaque psoriasis, with or without PsA, for at least 26 weeks prior to the first administration of study intervention.
- •Total BSA ≥10% at screening and baseline.
- •Total PASI ≥12 at screening and baseline.
- •Total IGA ≥3 at screening and baseline.
排除标准
- •1.Nonplaque form of psoriasis
- •2.Current drug-induced psoriasis
- •3.A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- •4.Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
- •5.Major surgical procedure (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study.
结局指标
主要结局
IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16.
IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16.
PASI 90 at Week 16.
PASI 90 at Week 16.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (78)
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