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A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

NCT06095128 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-03-18

No results posted yet for this study

Summary

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.

All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.

Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab IV infusions

DRUG

Tofacitinib

Tofacitinib Tablets

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2027-07-09
Completion
2027-07-09
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095128 on ClinicalTrials.gov