NCT06095596Recruiting
Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 334 (estimated)
- First submitted
- 11 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Ulcerative colitis
- NCT number
- NCT06095596
What you commit to
- Study type: Interventional
- Planned participants: 334
- From 1 Nov 2023 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
- 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
Other illness
- 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
Other
- Evidence of toxic megacolon was found during screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
Related publications
- Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial.Clin Gastroenterol Hepatol · 2026 · PMID 42173298
This page is information, not medical advice. Discuss any trial with your doctor.