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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
Sixth Affiliated Hospital, Sun Yat-sen UniversityClinicalTrials.govdrug
Study focus
Disease/Condition
Crohn Disease
Drug/Device/Intervention
Upadacitinib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Location
Guangzhou, China
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2023
End date
Oct 31, 2026
Enrollment
334 participants
Primary outcome

8th-week endoscopic remission rate,normalization rate of CRP at the 8th week,Clinical remission and response rate at the 8th week,life quality score at the 8th week

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease of small intestineCrohn disease [regional enteritis]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06095596
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06095596 through Pure Global AI's free database. This phase not specified trial is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University and is currently Recruiting. The study focuses on Crohn Disease. Target enrollment is 334 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.