Real-World Study on the Safety and Effectiveness of IL-23 Inhibitors for Inflammatory Bowel Disease in China

Официальное название

Efficacy and Safety of Interleukin-23 Inhibitors (IL-23i) in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study

Обзор

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Interleukin-23 (IL-23), a member of the IL-12 cytokine family, plays a role in maintaining intestinal homeostasis but is also involved in the pathogenesis of IBD. IL-23 is a heterodimer composed of p19 and p40 subunits linked by a disulfide bond. Humanized monoclonal antibodies selectively targeting the IL-23 p19 subunit have emerged as promising therapies for IBD. Recently, selective IL-23p19 inhibitors-risankizumab (Risan) and mirikizumab-have been approved for the treatment of moderately to severely active CD and UC, respectively. In addition, these agents, along with guselkumab (Gus), are undergoing clinical trials for both CD and UC (guselkumab, gus, and mirikizumab for CD; guselkumab and risankizumab for UC). Guselkumab (Gus) and risankizumab (Risan), both targeting the IL-23 p19 subunit, have been approved in China for the treatment of CD, with guselkumab also approved for UC. However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese IBD populations is lacking. This is a multicenter, single-arm, prospective, observational real-world study designed to evaluate the efficacy and safety of IL-23i in adult UC and CD patients in routine clinical practice in China.

Вмешательства

• Препарат Interleukin-23 Inhibitors (IL-23i)
  Adult patients will receive treatment with an interleukin-23 inhibitor (IL-23i), including guselkumab or risankizumab, as prescribed in routine clinical practice in China. This observational study does not mandate dosing, administration schedule, or concomitant medications; treatments follow standard of care. Patients will be prospectively monitored for clinical effectiveness, endoscopic outcomes, and safety over 52 weeks.

Первичные конечные точки

• clinical remission rate [Срок оценки: Week 52]

Вторичные конечные точки (4)

• clinical response rate [Срок оценки: week 52]
• endoscopic remission rate [Срок оценки: Week 52]
• endoscopic response rate [Срок оценки: week 52]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) through Week 52 [Срок оценки: Week 52]

Критерии участия

Критерии включения

Adults aged 18 years or older, any gender. Formally diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). Determined by the treating physician to require initiation of IL-23 inhibitor (IL-23i) therapy for the first time.

Критерии исключения

Currently enrolled in or planning to participate in any other interventional clinical study.

Contraindications to IL-23i treatment as specified in the drug label. Considered by the investigator to be unsuitable for participation in the study for any reason.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07184138 · 20250913

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗