NCT07181525

Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Inflammatory bowel disease (IBD) is a group of chronic progressive gastrointestinal diseases that can recur throughout life and for which there is no cure. Biologics, the first line of treatment, are not only expensive, but also 30-50% of patients lack response to this type of drug therapy. However, there is a lack of reliable methods to predict the clinical efficacy of biologics. The aim of this study is to construct a reliable model to predict patients' response to biologics therapy by comprehensively analysing patients' clinical characteristics, biomarkers and other information to guide individualized therapy. In this study, we will collect clinical data from IBD patients at Peking University First Hospital, including but not limited to patients' baseline characteristics, biomarker levels, and efficacy responses, etc. We will establish a complete patient dataset using a cohort study, train and test the dataset by applying correlation analysis, multiple regression analysis, and machine learning algorithms (e.g. neural networks etc), establish and compare the prediction effects of different models The optimal model is selected for encapsulation and developed into a user-friendly clinical prediction tool. This study will contribute to clinical decision making for IBD patients, improve treatment outcomes, and reduce unnecessary healthcare costs.

Conditions

• Inflamatory Bowel Disease

Interventions

Type	Name	Description
DRUG	anti-cytokine antibodies	Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies)
DRUG	anti-integrin antibodies	Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-07-01
• Completion: 2026-12-31
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: China