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Vedolizumab + Tofacitinib for Ulcerative Colitis

Phase 4

Recruiting

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].

Must not have

Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment.

Has any of the following UC-related complications:

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a Clostridium difficile infection or treatment for any intestinal pathogen in the last 28 days.

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I have complications related to ulcerative colitis.

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I have had an ileostomy, colostomy, or a blockage in my intestine.

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My bile duct inflammation is not under control.

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I have tuberculosis, whether currently active or inactive.

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I haven't taken any drugs or supplements that affect CYP3A4 in the last 2 weeks.

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I have not received a live vaccine in the last 4 weeks and won't during or for 12 weeks after the study.

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I have severe heart failure (NYHA class III or IV) diagnosed in the last 6 months.

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I have or might have a disease related to my lymph nodes or spleen.

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I have a specific type of colitis not related to ulcerative colitis.

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My TB skin test reaction is at least 10 mm, or 5 mm if I'm on high-dose steroids.

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I currently have an active infection.

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I have had a major surgery to remove part or all of my colon.

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I have an abdominal abscess or severe colon swelling.

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I regularly take NSAIDs or acetaminophen in high doses.

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I have short bowel syndrome.

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I have severe ulcerative colitis.

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I have had blood clots in my veins or lungs before.

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I have a genetic condition that increases my risk of blood clots.

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I have had tuberculosis in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 4

~32260

Vedolizumab

2009

Completed Phase 4

~10220