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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Adalimumab Solution for Injection
  Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis. In March 2020, adalimumab was approved in China for the treatment of severe plaque psoriasis in children and adolescents aged four years and older who have not responded well to topical therapies and phototherapy or are unsuitable for such treatments.

Первичные конечные точки

• Psoriasis Area and Severity Index 75 at week 16 [Срок оценки: Week 16]

Вторичные конечные точки (6)

• Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52 [Срок оценки: Week 8, Week 32, Week 52]
• Psoriasis Area and Severity Index 90 [Срок оценки: Week 8, Week 16, Week 32, Week 52]
• Psoriasis Area and Severity Index 100 [Срок оценки: Week 8, Week 16, Week 32, Week 52]
• Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1) [Срок оценки: Week 8, Week 16, Week 32, Week 52]
• Children's Dermatology Life Quality Index (CDLQI) score [Срок оценки: Week 8, Week 16, Week 32, Week 52]
• Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs [Срок оценки: Up to 54 weeks]

Критерии участия

Критерии включения

• 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)"

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07529925 · ADM-IV-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗