RecruitingNot ApplicableNCT06095596

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

334 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether using two different anti-inflammatory medications together — vedolizumab (an infusion) and upadacitinib (a daily oral pill) — is a safe and effective treatment strategy for people with moderate to severe ulcerative colitis (UC), a chronic bowel disease causing inflammation and ulcers in the colon. **You may be eligible if...** - You have had a confirmed UC diagnosis for at least 3 months, with colonoscopy and biopsy evidence - Your UC is moderately to severely active (based on a modified Mayo scoring system) - You are indicated for vedolizumab or upadacitinib based on your doctor's assessment **You may NOT be eligible if...** - You cannot take oral upadacitinib or receive regular IV vedolizumab infusions - You have evidence of toxic megacolon (dangerous bowel complication) - You have had major bowel surgery (large bowel removal, ileostomy, or colostomy) - You need surgery for UC or plan to have elective surgery during the study - You have severe, progressive, or uncontrolled disease complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUpadacitinib

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

DRUGVedolizumab

Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.


Locations(1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT06095596


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