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Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease

NCT07597577 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2026-05-19

No results posted yet for this study

Summary

Background \& Aims: Isolated small bowel Crohn's disease (CD) is defined by involvement of the ileum, jejunum, or extensive small intestinal segments in the absence of colonic disease. This phenotype presents a therapeutic challenge, as biologic agents demonstrate reduced efficacy in this subgroup. Data on the use of upadacitinib specifically for isolated small bowel CD remain limited. This study aimed to evaluate the efficacy of upadacitinib in patients with this phenotype using the International Bowel Ultrasound Segment Activity Score (IBUS-SAS).

Methods: A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted. Based on whether the disease involved the small bowel, individuals were categorized into an isolated small bowel CD group and a non-small bowel CD group. The primary endpoint was the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) from baseline to week 12. Secondary endpoints at week 12 included radiographic response (defined as a\>25% or\>2.0 mm reduction in bowel wall thickness \[BWT\] from baseline, or a\>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade), change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI) from baseline, and changes in laboratory parameters (C-reactive protein, erythrocyte sedimentation rate). Statistical analyses included between-group comparisons, within-group comparison and logistic regression to identify predictors of radiographic response.

Conditions

  • Crohn Disease
  • Upadacitinib

Interventions

DRUG

Upadacitinib

A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-12
Primary Completion
2024-10-12
Completion
2026-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597577 on ClinicalTrials.gov