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NCT06095128Not yet recruiting

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

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis
TakedaPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Vedolizumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Location
Los Angeles, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Jan 29, 2024
End date
Jul 09, 2027
Enrollment
65 participants
Primary outcome

Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score

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.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06095128
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06095128 through Pure Global AI's free database. This Phase 4 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 65 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.