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

NCT07597577 | Completed

• 1 other identifier: 2026ZSLYEC-305
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS)

  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 Outcomes (4)

• radiographic response

  at week 12

• change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI)

  from baseline to week 12

• changes in laboratory parameters (C-reactive protein）

  from baseline to week 12

• changes in laboratory parameters (Erythrocyte sedimentation rate)

  from baseline to week 12

Study Arms (2)

case group：isolated small bowel Crohn's disease group

Drug: Upadacitinib

control group：a non-small bowel Crohn's disease group

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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.

case group：isolated small bowel Crohn's disease group; control group：a non-small bowel Crohn's disease group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangzhou, 510000, China

Location

Related Publications (3)

• Dulai PS, Singh S, Vande Casteele N, Boland BS, Rivera-Nieves J, Ernst PB, Eckmann L, Barrett KE, Chang JT, Sandborn WJ. Should We Divide Crohn's Disease Into Ileum-Dominant and Isolated Colonic Diseases? Clin Gastroenterol Hepatol. 2019 Dec;17(13):2634-2643. doi: 10.1016/j.cgh.2019.04.040. Epub 2019 Apr 19.

  PMID: 31009791 BACKGROUND

• Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.

  PMID: 16698746 BACKGROUND

• Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.

  PMID: 38437854 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start: March 12, 2023
• Primary Completion: October 12, 2024
• Study Completion: May 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)