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NCT Number: NCT06922331

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

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.

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Key information

Conditions

Crohn's Disease (CD) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Geriatric Ulcerative Colitis Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Pediatric Crohn's Disease Refractory Crohn's Disease Refractory Ulcerative Colitis Ulcerative Colitis (UC)

Age range

9 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 515000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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))

Exclusion criteria

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

Treatment and study plan

Upadacitinib

Drug

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

Primary outcomes

  1. Clinical Remission Rate at Week 12

    Time frame: 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].

  2. Endoscopic Response Rate at Week 12

    Time frame: 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].

Secondary outcomes

  1. Clinical Response Rate at Week 12

    Time frame: Week 12

    The proportion of patients achieving clinical response at 12 weeks, as defined by [Specify the definition of clinical response, e.g., "a decrease of ≥ 3 points from baseline in the Mayo score" for UC or "a decrease of ≥ 20 points from baseline in the PCDAI score" for CD].

  2. Change in CRP from Baseline to Week 12

    Time frame: Baseline to Week 12

    The change in C-reactive protein (CRP) levels from baseline to 12 weeks after treatment initiation.

Other outcomes

  1. Incidence of Adverse Events

    Time frame: Week 0 to Week 12

    The number and type of adverse events occurring during the 12-week treatment period.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: UPA-AGE

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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