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Набор скоро начнётся NCT06802848

Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)

— Наблюдательное Plaque Psoriasis Psoriatic Arthritis Scalp Psoriasis Nail Psoriasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Xeligekimab injection.
Кому может быть актуально
Состояния в реестре: Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis, Nail Psoriasis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Effectiveness and Safety of Xeligekimab in Adult Patients With Moderate to Severe Plaque Psoriasis: A Multicenter, Prospective, Real-World Study

Обзор

Xeligekimab Injection was approved in China on August 20, 2024, for treating adults with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy. Despite the promising efficacy and safety shown in the phase III clinical trial, real-world data is needed to further support clinical decisions for this patient group. This study aims to evaluate the effectiveness and safety of xeligekimab in real-world clinical settings for adults with moderate to severe plaque psoriasis.

Подробное описание

This multicenter, prospective, real-world study will consecutively enroll moderate to severe plaque psoriasis adult patients who are anticipated to receive xeligekimab for the first time. All patients will receive routine clinical care. The study will evaluate the treatment's effectiveness and safety and observe treatment patterns for up to 52 weeks.

Objectives:

Primary Objective:

To evaluate the effectiveness and safety of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice.

Secondary Objective:

To observe the treatment patterns of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice.

Exploratory Objectives:

* To explore the effectiveness of xeligekimab in subgroup patients with psoriatic arthritis. * To explore the effectiveness of xeligekimab in subgroup patients with psoriasis involving special areas (scalp, nails, palmoplantar areas, genital areas, etc.). * To explore the effectiveness of xeligekimab in subgroup patients with comorbidities of psoriasis. * To explore the effectiveness and safety of xeligekimab in subgroup patients with psoriasis who have previously received treatment with other biologic agents.

Вмешательства

  • Препарат Xeligekimab injection
    This is a real-world study. All treatment regimens are developed and implemented through detailed communication between patients and their treating clinicians. Treatment recommendations are consistent with the medication's prescribing information and treatment guidelines. The recommended dosing for xeligekimab is 200 mg at weeks 0, 2, 4, 6, 8, 10, and 12, followed by every 4 weeks thereafter. Each 200 mg dose is given in 2 separate 100 mg subcutaneous injections. The preferred injection site is

Первичные конечные точки

  • Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12 [Срок оценки: Week 12]
Вторичные конечные точки (8)
  • PASI90 response rates at Weeks 4, 24, 36, and 52 [Срок оценки: Weeks 4, 24, 36, and 52]
  • PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52 [Срок оценки: Weeks 4, 12, 24, 36, and 52]
  • Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52 [Срок оценки: Weeks 4, 12, 24, 36, and 52]
  • Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52 [Срок оценки: Weeks 4, 12, 24, 36, and 52]
  • Treatment patterns: treatment statuses [Срок оценки: Weeks 12, 24, 36, and 52]
  • Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy [Срок оценки: Weeks 12, 24, 36, and 52]
  • Treatment patterns: treatment regimens after switching [Срок оценки: Weeks 12, 24, 36, and 52]
  • Adverse Events (AEs) [Срок оценки: Week 52]

Критерии участия

Критерии включения

Patients who meet all the following criteria will be included in this study:

  • Patients 18 years of age or older;
  • Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;
  • Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;
  • Patients who are willing to sign the informed consent form.

Критерии исключения

Patients who meet any of the following exclusion criteria will be excluded from this study:

  • Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
  • Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
  • Patients with other contraindications specified in the prescribing information;
  • Patients concurrently participating in other clinical studies;
  • Patients under other conditions or circumstances that investigators do not consider appropriate to include.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Xiangya Hospital of Central South University — Hunan

Идентификаторы

NCT: NCT06802848 · GRRWS202401

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗