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Vedolizumab + Tofacitinib for Ulcerative Colitis

Phase 4

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has moderately to severely active UC as determined by a complete Mayo score [including physician's global assessment (PGA)] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.

Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 2, 6, 8, 14, 26, 42 and 52

Awards & highlights

Study Summary

This trial will test the effectiveness of vedolizumab+tofacitinib and vedolizumab alone in treating adults with moderate-severe UC. Participants will receive vedolizumab+tofacitinib for 8 weeks and then be monitored for response. Those who show response will receive vedolizumab alone for 44 weeks.

Who is the study for?

Adults with moderate to severe ulcerative colitis (UC) diagnosed at least 3 months ago, who haven't responded well or are intolerant to up to two TNF antagonists. They should have UC extending beyond the rectum and be current on colorectal cancer screenings if at risk. Participants can't join if they've had major colon surgery, certain infections like hepatitis B/C or TB, recent heart issues, or a history of lymphoproliferative disease.Check my eligibility

What is being tested?

The trial is testing vedolizumab IV in combination with tofacitinib for adults with UC for the first 8 weeks. Those responding will continue vedolizumab alone for another 44 weeks. The study aims to understand the effects of this combined treatment followed by monotherapy with vedolizumab.See study design

What are the potential side effects?

Possible side effects include infection risks due to immune system suppression, liver issues, headaches, nausea, and potential increased risk of blood clots. Vedolizumab may cause infusion-related reactions while Tofacitinib could lead to higher cholesterol levels and liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ulcerative colitis is moderate to severe, with active symptoms.

Select...

My ulcerative colitis affects more than 15 cm of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 2, 6, 8, 14, 26, 42 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 2, 6, 8, 14, 26, 42 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 6, 8, 14, 26, 42 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in C-Reactive Protein Levels (CRP) From Baseline

Change in Fecal Calprotectin Concentrations From Baseline

Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline

+17 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vedolizumab 300 mg + Tofacitinib 10 mgExperimental Treatment2 Interventions

Participants will receive Vedolizumab 300 mg , intravenous (IV) infusion, at Week 0, Week 2 and Week 6 along with Tofacitinib 10 mg, tablets, orally, twice daily from Week 0 to Week 8. Participants with clinical response at Week 8 will transition to receive vedolizumab 300 mg IV infusion every 8 weeks (Q8W) through Week 46.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tofacitinib

2018

Completed Phase 3

~39970

Vedolizumab

2009

Completed Phase 4

~10330

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,206 Previous Clinical Trials

4,188,004 Total Patients Enrolled

23 Trials studying Ulcerative Colitis

9,189 Patients Enrolled for Ulcerative Colitis

Study DirectorStudy DirectorTakeda

1,215 Previous Clinical Trials

499,549 Total Patients Enrolled

23 Trials studying Ulcerative Colitis

9,742 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of 85 years or younger permitted to join this trial?

"This clinical trial has an age range of 18-65 years old; any patient outside this range is without eligibility."

Answered by AI

Are my characteristics compatible with the criteria for this research venture?

"In order to qualify for this medical trial, participants must have a diagnosis of ulcerative colitis and be between 18 and 65. Currently, there is space in the study for approximately 65 volunteers."

Answered by AI

To what degree could Vedolizumab 300 mg + Tofacitinib 10 mg endanger patient safety?

"The safety of Vedolizumab 300 mg + Tofacitinib 10 mg was evaluated by the Power team and assigned a score of 3, as this treatment has already been approved in Phase 4 trials."

Answered by AI

Are there still opportunities to enroll in this clinical experiment?

"According to the information available on clinicaltrials.gov, this experiment is no longer recruiting patients. It was initially launched in January 2024 and last edited in October 2023. Fortunately, there are 439 other studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095128.

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