NCT06922331

Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

Age-Stratified Efficacy of Upadacitinib in Refractory Inflammatory Bowel Disease Among Asian Populations: Pediatric Crohn's Disease Versus Elderly Ulcerative Colitis Cohort Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 9 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This single-center, retrospective study aims to evaluate the effectiveness and safety of upadacitinib (UPA) in Asian pediatric patients with refractory Crohn's disease (CD) and elderly patients with refractory ulcerative colitis (UC). The study will analyze data from 21 patients (11 children aged 9-17 with CD and 10 adults aged 60 and older with UC) treated at the Sixth Affiliated Hospital of Sun Yat-sen University between January 2023 and December 2024. The primary objective is to assess the clinical remission rate and endoscopic response rate in both groups. Secondary objectives include comparing treatment outcomes between the two age groups, exploring the impact of immunosenescence on UPA efficacy in elderly UC patients, and analyzing the correlation between laboratory markers (CRP, albumin) and clinical outcomes. This study is the first in Asia to investigate the age-stratified efficacy of upadacitinib in pediatric CD and elderly UC patients. The findings will provide crucial real-world evidence to inform individualized treatment strategies for these specific populations. Patients included in this study will have previously failed at least two biological therapies. Data collected will include demographics, disease characteristics, prior treatment history, UPA dosage and duration, clinical and endoscopic scores (PCDAI/Mayo, SES-CD/UCEIS), imaging results, laboratory values, and adverse events. The study is registered on ClinicalTrials.gov (NCT06274996). Ethical considerations will be addressed through data anonymization and a waiver of informed consent due to the retrospective nature of the study.

Conditions

• Crohn's Disease (CD)
• Ulcerative Colitis (UC)
• Refractory Crohn's Disease
• Refractory Ulcerative Colitis
• Inflammatory Bowel Disease (IBD)
• Pediatric Crohn's Disease
• Geriatric Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Upadacitinib	A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study