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Recruiting NCT06095596

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

No phase Interventional Ulcerative Colitis (UC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upadacitinib, Vedolizumab.
Who it may be relevant to
Registry conditions: Ulcerative Colitis (UC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study

Overview

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.

Interventions

  • Drug Upadacitinib
    Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
  • Drug Vedolizumab
    Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Primary outcome measures

  • 8th-week endoscopic remission rate [Time frame: 8th-week]
Secondary outcome measures (11)
  • Clinical remission rate at the 8th week [Time frame: 8th-week]
  • clincial response rate at 8th-week [Time frame: 8th-week]
  • Endoscopic response rate at 8th-week [Time frame: 8th-week]
  • normalization rate of CRP at the 8th week [Time frame: 8th-week]
  • life quality score at the 8th week [Time frame: 8th-week]
  • Clinical remission rate at the 54th-week [Time frame: 54th-week]
  • Clinical response rate at 54th week [Time frame: 54th week]
  • endoscopic remission rate at 54th-week [Time frame: 54th-week]
  • Endoscopic response rate at 54th-week [Time frame: 54th-week]
  • normalization rate of CRP at the 54th week [Time frame: 54th-week]
  • life quality score at the 54th week [Time frame: 54th-week]

Eligibility criteria

Inclusion criteria

  • Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
  • Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
  • Indications for VDZ or UPA application

Exclusion criteria

  • Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
  • Evidence of toxic megacolon was found during screening
  • Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
  • Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
  • There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
  • Evidence of active hepatitis B or C infection during screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou

Publications

  • Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online a PMID 42173298

Identifiers

NCT: NCT06095596 · 2023ZSLYEC-469

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗