Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
Status:
Recruiting
Trial end date:
2026-10-31
Target enrollment:
Participant gender:
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.