The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis

Официальное название

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis

Обзор

The purpose of this study is to assess efficacy, safety of subcutaneous SHR-1314 in pediatric patients of age 6 to \<18 years with moderate-to-Severe plaque psoriasis

Вмешательства

• Препарат SHR-1314
  SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3

Первичные конечные точки

• Safety assessment including adverse events at Week 16 [Срок оценки: Week 16]
• PK parameters: Cmax at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (3)

• Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12 [Срок оценки: Week 12]
• sPGA of 0 or 1 response at Week 12 [Срок оценки: Week 12]
• Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90)at Week 12 [Срок оценки: Week 12]

Критерии участия

Критерии включения

• between 6 and 18years of age at time of screening.
• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
• Moderate to severe psoriasis as defined at Baseline/ randomization by:

PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.

Критерии исключения

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
• Drug-induced psoriasis.
• Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
• Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
• History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
• At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• History of congestive heart failure (New York Heart Association \[NYHA\] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
• Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization.
• History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide.
• All subjects will be tested for tuberculosis status using IGRA and X-ray test.
• Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
• Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.

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

Китай · 2 центра

• Capital Medical University Affiliated Children's Hospital — Пекин
• Shanghai Huashan Hospital — Шанхай

Идентификаторы

NCT: NCT06833307 · SHR-1314-307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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