Status:
RECRUITING
Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT06095596
Start Date
November 1 2023
End Date
October 31 2026
Last Update
August 28 2025
Active Locations (1)
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1
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 501655