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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT06095596
Status
Recruiting
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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
  • Vedolizumab — DRUG
    Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
334 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination treatment group
    A combination treatment of vedolizumab and upadacitinib for 8 weeks in the induction therapy, then followed by a single treatment of vedolizumab in the maintenance therapy
  • Placebo Comparator: Single treatment group
    single treatment of vedolizumab both in the induction and maintenance therapy

Primary Outcome Measure

8th-week endoscopic remission rate [ Time Frame: 8th-week ]

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