Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis

NCT07442045 | Recruiting DMC

• 1 other identifier: 2026ZSLYEC-079
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter retrospective cohort study evaluates the real-world effectiveness and safety of upadacitinib used alone or in combination with vedolizumab in adult patients with moderate-to-severe ulcerative colitis (UC). UC is a chronic inflammatory bowel disease that often requires long-term management, and monotherapy may reach a therapeutic ceiling in clinical practice. Combination therapy with upadacitinib, a rapid-acting oral JAK inhibitor, and vedolizumab, a gut-selective biologic, may provide complementary benefits. The study uses existing clinical and laboratory data from six Chinese IBD centers to compare short-term outcomes, including clinical remission, clinical response, endoscopic remission, normalization of C-reactive protein, and occurrence of adverse events during the 8-week induction period. This study reflects routine clinical practice and aims to provide real-world evidence to support treatment decisions in patients with moderate-to-severe UC.

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis; Upadacitinib; Vedolizumab; Combination Therapy; Real-World Study

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate at the 8th-week

  Clinical remission is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0.

  8th-week

Secondary Outcomes (3)

• Clincial response rate at the 8th week

  8th-week

• CRP normalization rate at the 8th week

  8th-week

• Endoscopic remission rate at the 8th week

  8th-week

Other Outcomes (1)

• Incidence of Adverse Events

  Week 0 to Week 8

Study Arms (2)

Combination treatment group

A combination treatment of Upadacitinib and Vedolizumab for 8 weeks in the induction therapy.

Drug: Upadacitinib; Drug: Vedolizumab

Single treatment group

Single treatment of Upadacitinib in the induction therapy

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.

Combination treatment group; Single treatment group

Vedolizumab DRUG

Vedolizumab 300mg intravenously on weeks 1, 2, 6.

Combination treatment 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

The study population consists of adult patients (≥18 years) with a confirmed diagnosis of ulcerative colitis (UC) who received upadacitinib either as monotherapy or in combination with vedolizumab in routine clinical practice at participating six tertiary inflammatory bowel disease centers in China. Eligible patients were identified through institutional pharmacy databases and electronic medical records. All included patients had active moderate-to-severe UC at baseline, defined by a modified Mayo score ≥4 and an endoscopic subscore ≥2. Patients were treated according to physician discretion in real-world settings.

You may qualify if:

• Age ≥18 years at the time of treatment initiation.
• Established diagnosis of ulcerative colitis (UC) for at least 3 months prior to index date, confirmed by compatible clinical presentation, endoscopic findings, and histopathological evidence.
• Moderately to severely active disease at baseline, defined as a modified Mayo score ≥4 with an endoscopic subscore (ESS) ≥2.
• Initiation of treatment with upadacitinib, either as monotherapy or in combination with vedolizumab, in routine clinical practice at participating centers.
• Availability of baseline clinical assessment and follow-up data at 8 weeks after initiation of upadacitinib.

You may not qualify if:

• Diagnosis of Crohn's disease, indeterminate colitis, or other non-UC colitis.
• Prior colectomy or planned colectomy at the time of treatment initiation.
• Participation in an interventional clinical trial involving upadacitinib during the study period.
• Insufficient clinical data to assess baseline disease activity or week 8 outcomes.
• Concomitant use of other advanced therapies (biologics or small molecules) initiated after the index date, except for vedolizumab in the combination group.

Sponsors & Collaborators

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

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 501655, China

RECRUITING

Related Publications (6)

• Battat R, Chang JT, Loftus EV Jr, Sands BE. IBD Matchmaking: Rational Combination Therapy. Clin Gastroenterol Hepatol. 2025 Feb;23(3):469-479. doi: 10.1016/j.cgh.2024.05.051. Epub 2024 Jul 25.

  PMID: 39025253 BACKGROUND

• Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

  PMID: 23964932 BACKGROUND

• Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.

  PMID: 35644166 BACKGROUND

• Raine T, Danese S. Breaking Through the Therapeutic Ceiling: What Will It Take? Gastroenterology. 2022 Apr;162(5):1507-1511. doi: 10.1053/j.gastro.2021.09.078. Epub 2022 Jan 4.

  PMID: 34995533 BACKGROUND

• Alsoud D, Verstockt B, Fiocchi C, Vermeire S. Breaking the therapeutic ceiling in drug development in ulcerative colitis. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):589-595. doi: 10.1016/S2468-1253(21)00065-0. Epub 2021 May 19.

  PMID: 34019798 BACKGROUND

• Singh S, Loftus EV Jr, Limketkai BN, Haydek JP, Agrawal M, Scott FI, Ananthakrishnan AN; AGA Clinical Guidelines Committee. Electronic address: clinicalpractice@gastro.org. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2024 Dec;167(7):1307-1343. doi: 10.1053/j.gastro.2024.10.001.

  PMID: 39572132 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinib; vedolizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiayin Yao

CONTACT

13826462890; yjyin@mail3.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: January 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)