Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

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

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 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
    China

    Active - Recruiting

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