CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Upadacitinibdrug
Likely dose
Upadacitinib 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07597577
NCT07597577N/ACompleted

Comparable Efficacy of Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease: A Retrospective Cohort Study

Sixth Affiliated Hospital, Sun Yat-sen University·observational·Posted May 19, 2026·Updated May 19, 2026

In Brief

An observational study evaluating Upadacitinib for Crohn Disease and Upadacitinib. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 19, 2026
Enrollment StartMar 12, 2023
Primary CompletionOct 12, 2024
Study CompletionMay 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 1 month ago

Interventions

Upadacitinibdrug

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.