NCT06095596

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

Recruiting now NA Last updated 28 August 2025

What this trial tests

NA trial testing Upadacitinib in Ulcerative Colitis (UC) in 334 participants. Currently enrolling.

Timeline

1 November 2023

Primary endpoint
31 October 2025

31 October 2026

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	334
Start date	1 November 2023
Primary completion	31 October 2025
Estimated completion	31 October 2026
Sites	1 location across China

Drugs / interventions tested

• Upadacitinib — full drug profile →
• Vedolizumab (vedolizumab) — full drug profile →

Conditions studied

• Ulcerative Colitis (UC) — all drugs for Ulcerative Colitis (UC) →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

18 and older, any sex, with Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dual Therapy in Inflammatory Bowel Disease.
   Altieri G, Zilli A, Parigi TL, Allocca M, et al · · 2025 · cited 11× · PMID 40001525 · DOI 10.3390/biom15020222
2. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial.
   Yao J, Wu H, Wu L, Yu Q, et al · · 2026 · PMID 42173298 · DOI 10.1016/j.cgh.2026.05.010
3. [Advances in the clinical management of acute severe ulcerative colitis].
   Shao W, Zhou Y, Xu F. · · 2026 · PMID 41974572 · DOI 10.3724/zdxbyxb-2025-0382