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

NCT06922331 | Completed FDA Drug

• 1 other identifier: 2025ZSLYEC-149
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Clinical Remission Rate at Week 12

  he proportion of patients achieving clinical remission at 12 weeks, as defined by \[Specify the definition of clinical remission, e.g., "a Mayo score ≤ 2 with no individual subscore \> 1" for UC or "a PCDAI score \< 10" for CD\].

  Week 12

• Endoscopic Response Rate at Week 12

  The proportion of patients achieving endoscopic response at 12 weeks, as defined by \[Specify the definition of endoscopic response, e.g., "a decrease of ≥50% from baseline in the SES-CD score" for CD or "a decrease of ≥ 1 point from baseline in the UCEIS" for UC\].

  Week 12

Secondary Outcomes (2)

• Clinical Response Rate at Week 12

  Week 12

• Change in CRP from Baseline to Week 12

  Baseline to Week 12

Other Outcomes (1)

• Incidence of Adverse Events

  Week 0 to Week 12

Study Arms (2)

Pediatric Crohn's Disease (CD) Group

Patients aged 9-17 years diagnosed with refractory Crohn's disease who received upadacitinib treatment.

Drug: Upadacitinib

Elderly Ulcerative Colitis (UC) Group

Patients aged 60 years or older diagnosed with refractory ulcerative colitis who received upadacitinib treatment.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Elderly Ulcerative Colitis (UC) Group; Pediatric Crohn's Disease (CD) Group

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asian pediatric patients (ages 9-17) with refractory Crohn's disease and elderly patients (60 years and older) with refractory ulcerative colitis.

You may qualify if:

• Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))

You may not qualify if:

• Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 515000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)