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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
• Intervention / Treatment: Drug: Interleukin-23 Inhibitors (IL-23i)

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Kang Chao, Professor; Phone Number: +86586084; Email: chaokang3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients in China diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating treatment with an interleukin-23 inhibitor (IL-23i) for the first time in routine clinical practice.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult IBD Patients Treated With IL-23i; 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.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical remission rate	To evaluate the effectiveness of IL-23 inhibitors (IL-23i) in real-world adult patients with ulcerative colitis (UC) or Crohn's disease (CD) by assessing clinical remission at Week 52	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical response rate	To assess the real-world effectiveness of IL-23i in adult UC or CD patients by evaluating clinical response at Week 52	week 52
endoscopic remission rate	To evaluate endoscopic remission at Week 52 in adult UC or CD patients receiving IL-23i in routine clinical practice	Week 52
endoscopic response rate	To evaluate endoscopic response at Week 52 in adult UC or CD patients receiving IL-23i in routine clinical practice	week 52
Incidence of adverse events (AEs) and serious adverse events (SAEs) through Week 52	To assess the safety of IL-23i in adult UC and CD patients by recording all adverse events (AEs) and serious adverse events (SAEs) occurring during the 52-week observation period	Week 52

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: September 13, 2025
• First Submitted That Met QC Criteria: September 13, 2025
• First Posted (Estimated): September 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Crohn's disease; IL23i
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 20250913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No