A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis

A Multicenter, Open-label Study on the Efficacy and Safety of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis

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.

Inclusion Criteria:

• 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)"

Exclusion Criteria:

• 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.