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

Crohn Disease Clinical Trial

Official title:

Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095596
• Other study ID #: 2023ZSLYEC-469
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease

Intervention

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

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	8th-week endoscopic remission rate	endoscopic subscale (ESS) =0, which defined as endoscopic remission	8th-week
Primary	normalization rate of CRP at the 8th week	normalization rate of C reactive protein (CRP)	8th-week
Primary	Clinical remission and response rate at the 8th week	Clinical remission and response rate	8th-week
Primary	life quality score at the 8th week	Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.	8th-week
Secondary	normalization rate of CRP at the 54th week	normalization rate of CRP	54th-week
Secondary	Clinical remission and response rate at the 54th-week	Clinical remission and response rate	54th-week
Secondary	life quality score at the 54th week	Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.	54th-week