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

NCT ID: NCT06095596

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Ulcerative Colitis (UC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.

Vedolizumab

Intervention Type: DRUG

Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Single treatment group

single treatment of vedolizumab both in the induction and maintenance therapy

Group Type: PLACEBO_COMPARATOR

Vedolizumab

Intervention Type: DRUG

Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Interventions

Upadacitinib

Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.

Intervention Type: DRUG

Vedolizumab

Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Intervention Type: DRUG

Other Intervention Names

Upadacitinib treatment; Vedolizumab treatment

Eligibility Criteria

Inclusion Criteria

• Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
• Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
• Indications for VDZ or UPA application

Exclusion Criteria

• Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
• 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 the study period
• There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
• Evidence of active hepatitis B or C infection during screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jiayin Yao

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jiayin Yao, Professor

Role: primary

yjyin@mail3.sysu.edu.cn

13826462890

Other Identifiers

2023ZSLYEC-469

Identifier Type: -

Identifier Source: org_study_id