NCT07529925尚未招募4 期
A Multicenter, Open-label Study on the Efficacy and Safety of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Psoriasis Area and Severity Index 75 at week 16
研究概览
简要总结
This study is a real-world clinical study of adalimumab. The project plans to enrol 30 participants and aims to evaluate the efficacy and safety of adalimumab in Chinese children with plaque psoriasis, with the primary endpoint being the proportion of participants achieving PASI 75 (PASI score reduction ≥75% from baseline) at week 16.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects and their guardians must sign an informed consent form. The research protocol/informed consent form for data collection and data verification should comply with local laws and regulations.
- •Age 4 years ≤ age ≤ 17 years, regardless of gender;
- •Subjects weigh ≥ 15kg;
- •Subjects who respond poorly to local treatment and/or phototherapy or are unsuitable for such treatments;
- •Diagnosed with severe plaque psoriasis in children according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Pediatric Psoriasis (2021)"
排除标准
- •Based on the prescribing information of Adalimumab Solution for Injection and the judgment of the treating physician, the subject is not eligible for treatment with Adalimumab Solution for Injection;
- •Subjects who received psoralen combined with long-wave ultraviolet (UVA) therapy within 14 days prior to the screening period, or topical medium-wave ultraviolet (UVB) therapy within 7 days prior to the screening period;
- •Subjects who received non-biological systemic treatments for paediatric psoriasis within 14 days prior to the screening period;
- •Subjects who are currently using or have used other biological Disease-Modifying Antirheumatic Drug treatments within 12 weeks prior to the screening period;
- •Subjects with significantly active psoriasis within 12 weeks prior to enrolment;
- •Subjects who have received any live vaccine within 3 months prior to the first dose of Adalimumab Solution for Injection, or who plan to receive live vaccines during the study;
- •Subjects currently participating in other clinical studies;
- •Subjects deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
Adalimumab Solution for Injection 20mg/40mg
Experimental
For a body weight of 15 kg~30 kg, the initial dose is 20 mg, with 20mg administered every 2 weeks starting 1 week after the first dose. For a body weight ≥30 kg, the initial dose is 40 mg, with 40mg administered every 2 weeks starting 1 week after the first dose.
干预措施: Adalimumab Solution for Injection (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index 75 at week 16
时间窗: Week 16
The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline).
次要结局
- Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52(Week 8, Week 32, Week 52)
- Psoriasis Area and Severity Index 90(Week 8, Week 16, Week 32, Week 52)
- Psoriasis Area and Severity Index 100(Week 8, Week 16, Week 32, Week 52)
- Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1)(Week 8, Week 16, Week 32, Week 52)
- Children's Dermatology Life Quality Index (CDLQI) score(Week 8, Week 16, Week 32, Week 52)
- Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs(Up to 54 weeks)
研究者
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