Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
Not applicable · Testing Upadacitinib and Vedolizumab · 1 site · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Upadacitinib (a drug) and Vedolizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 334 participants are expected to take part.
- Start date: 2023-11-01.
- Main results expected around 2025-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- 8th-week endoscopic remission rate (8th-week)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 334 (estimated) |
| Start date | 2023-11-01 |
| Primary completion (est.) | 2025-10-31 |
| First posted | 2023-10-23 |
| Last updated | 2026-04-28 |
| 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 |
| ClinicalTrials.gov ID | NCT06095596 |
Interventions
- Upadacitinib (Drug)
Oral upadacitinib 45mg/d for 8 weeks in the induction therapy. - Vedolizumab (Drug)
Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| the Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.