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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Treatments: Drug: Interleukin-23 Inhibitors (IL-23i)

Study type: Observational

Funder types: Other

Identifiers

NCT07184138

20250913

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

178 participants in 1 patient group

Adult IBD Patients Treated With IL-23i

Description:

Adult patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) in China who are initiating treatment with an interleukin-23 inhibitor (IL-23i) in a real-world clinical practice setting. Patients will be observed prospectively for treatment effectiveness and safety outcomes.

Treatment:

Drug: Interleukin-23 Inhibitors (IL-23i)