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

May 18, 2026 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangzhou
      • Guangdong, Guangzhou, China, 510000
        • The Sixth Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective case-control study consecutively enrolled individuals with Crohn's disease who initiated upadacitinib treatment at The Sixth Affiliated Hospital of Sun Yat-sen University between March 2023 and December 2024.

Description

Inclusion Criteria:

  • confirmed diagnosis of Crohn's disease (CD) based on the 2023 Chinese clinical practice guidelines (Guangzhou);
  • initiated upadacitinib treatment (45 mg once daily) and completed at least 12 weeks of follow-up;
  • underwent intestinal ultrasound examinations both before treatment initiation and at week 12

Exclusion Criteria:

  • age <18 years;
  • concomitant use of other CD medications during upadacitinib treatment, including glucocorticoids, mesalazine, immunosuppressants, or biologics;
  • undergoing surgical intervention during the upadacitinib treatment period
  • history of other gastrointestinal diseases (e.g., ulcerative colitis, intestinal tuberculosis);
  • incomplete clinical data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group：isolated small bowel Crohn's disease group
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.
control group：a non-small bowel Crohn's disease group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS)
Time Frame: from baseline to week 12
The maximum value of IBUS-SAS (International Bowel Ultrasound Segment Activity Score) is 100. The theoretical minimum is 4, but the clinically effective minimum is 0. In general, the lower the score, the milder the intestinal inflammation.
from baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic response
Time Frame: at week 12
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
at week 12
change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI)
Time Frame: from baseline to week 12
The Crohn's Disease Activity Index (CDAI) has a theoretical maximum of 1100 and a theoretical minimum of 0. Consistent with the definition of disease activity in this scoring system, the lower the score, the lower the disease activity and the better the clinical status.
from baseline to week 12
changes in laboratory parameters (C-reactive protein）
Time Frame: from baseline to week 12
from baseline to week 12
changes in laboratory parameters (Erythrocyte sedimentation rate)
Time Frame: from baseline to week 12
from baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2023

Primary Completion (Actual)

October 12, 2024

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026ZSLYEC-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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