NCT06095596

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Oct 2026

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

October 11, 2023

Last Update Submit

April 22, 2026

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

  • 8th-week endoscopic remission rate

    endoscopic subscale (ESS) =0, which defined as endoscopic remission

    8th-week

Secondary Outcomes (11)

  • Clinical remission rate at the 8th week

    8th-week

  • clincial response rate at 8th-week

    8th-week

  • Endoscopic response rate at 8th-week

    8th-week

  • normalization rate of CRP at the 8th week

    8th-week

  • life quality score at the 8th week

    8th-week

  • +6 more secondary outcomes

Study Arms (2)

Combination treatment group

EXPERIMENTAL

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

Drug: UpadacitinibDrug: Vedolizumab

Single treatment group

PLACEBO COMPARATOR

single treatment of vedolizumab both in the induction and maintenance therapy

Drug: Vedolizumab

Interventions

UpadacitinibDRUG

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

Also known as: Upadacitinib treatment
Combination treatment group
VedolizumabDRUG

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

Also known as: Vedolizumab treatment
Combination treatment groupSingle treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinibvedolizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

November 1, 2023

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)