A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Официальное название

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

Обзор

The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.

Вмешательства

• Препарат Guselkumab (GUS)
  Guselkumab will be administered intravenously or by subcutaneous injection.

Первичные конечные точки

• Percentage of Participants Achieving Clinical Remission At Week 48 [Срок оценки: At Week 48]

Вторичные конечные точки (11)

• Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48 [Срок оценки: At Weeks 12, 24 and 48]
• Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24 [Срок оценки: At Weeks 12 and 24]
• Percentage of Participants Achieving Endoscopic Response [Срок оценки: At Weeks 24 and 48]
• Percentage of Participants Achieving Endoscopic Remission [Срок оценки: At Weeks 24 and 48]
• Baseline Characteristics of Participants With Endoscopic Remission: Age [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: Sex [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: Height [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: Weight [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities [Срок оценки: Baseline]
• Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Has a confirmed diagnosis of Crohn's disease (CD)
• Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 and either mean daily stool frequency (SF) count >= 4 or mean daily abdominal pain (AP) score >=2
• Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \[mg\]/kilogram \[kg\] intravenous \[IV\] followed by 90 mg subcutaneous \[SC\] at week 8) as the instruction manual
• Initially responded to UST induction therapy and then lose response to UST
• During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic

Критерии исключения

• Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
• Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
• Is currently enrolled in an interventional clinical study
• Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
• Have a current or be suspected to have an abscess

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 · 5 центров

• The First Affiliated Hospital Sun Yat sen University — Гуанчжоу
• The Sixth Affiliated Hospital Sun Yat sen University — Гуанчжоу
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Ханчжоу
• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT07310095 · CNTO1959CRD4007 · CNTO1959CRD4007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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