Study on the Mechanism of Treatment Response to IL-23 Monoclonal Antibody in Patients with Inflammatory Bowel Disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500111751

Enrollment

Unknown

Registered

2025-11-05

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

Observational group:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, inclusive; both male and female. 2. Patients with IBD who are scheduled to receive anti-IL-23 monoclonal antibody therapy as determined by a clinician, and have not been treated with other biologic agents within the last 2 months. 3. Able to understand and sign the Informed Consent Form (ICF), and able to tolerate endoscopic examination and biopsy procedures.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females. 2. Concomitant severe diseases that significantly impact immune function (e.g., severe hepatic or renal dysfunction, severe cardiovascular or cerebrovascular diseases, malignant tumors, etc.). 3. Known hypersensitivity or allergy to the IL-23 monoclonal antibody or its components.

Design outcomes

Primary

Measure	Time frame
Longitudinal changes in cellular composition and protein expression of intestinal mucosal tissue;	—

Countries

China

Contacts

Public ContactBai Xue

Shengjing Hospital of China Medical University

bx_ben@163.com+86 189 4025 1248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026