Last updated: November 21, 2023
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Vedolizumab
Upadacitinib
Clinical Study ID
NCT06095596
2023ZSLYEC-469
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC andhistopathological evidence supporting UC diagnosis
- Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 andendoscopic subscale (ESS) ≥ 2
- Indications for VDZ or UPA application
Exclusion
Exclusion Criteria:
- Patients who are unable to take oral UPA and receive regular intravenous VDZ infusiontherapy
- 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 thestudy period
- There is evidence indicating that the subjects suffer from severe, progressive, oruncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurologicaldiseases
- Evidence of active hepatitis B or C infection during screening
Study Design
Total Participants: 334
Treatment Group(s): 2
Primary Treatment: Vedolizumab
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
October 31, 2026
Connect with a study center
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong 501655
ChinaActive - Recruiting
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