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Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Phase 4 Interventional Takeda · NCT06581328

This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsvedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab, infliximab, adalimumab, certolizumab, ustekinumab, mirikizumab, risankizumab, tofacitinib, upadacitinib
Locations98 sites (Birmingham, Alabama and 97 other locations)
Trial IDNCT06581328 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Vedolizumab in adults with Ulcerative Colitis (UC) or Crohn's Disease (CD) over a treatment period of approximately one year. Participants will initially receive Vedolizumab intravenously for the first 6 weeks, followed by subcutaneous injections for the remainder of the treatment. The primary goal is to assess the rate of remission, defined as the disappearance of UC and CD symptoms, after 14 weeks of treatment. Participants who do not respond adequately by this time will discontinue the treatment and may switch to alternative therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have been diagnosed with Ulcerative Colitis or Crohn's Disease.

Not a fit: Patients who are not eligible due to non-compliance with protocol requirements or those who have not had their immunizations updated may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to significant symptom relief and improved quality of life for patients with UC and CD.

How similar studies have performed: Previous studies have shown positive outcomes with Vedolizumab in treating UC and CD, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

To be eligible to participate in this study, participants must meet all the following criteria:

1. In the investigator's opinion, the participant can understand and comply with protocol requirements.
2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
3. The participant is 18 to 80 years of age at the time of signing the ICF.
4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
5. If participant is a woman of childbearing potential (WOCBP):

   1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.
   2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.
   3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
   4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
6. If participant is a fertile man:

   1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
   2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.
7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:

   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR
   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening
8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.

Exclusion Criteria

Participants who meet any of the following exclusion criteria will be excluded from participation in this study:

1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening.
2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).
5. Received any investigational biologic therapy \<= 6 months prior to screening.
6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).
7. The participant has any evidence of an active infection during screening.
8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.
9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.
10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.
11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.
12. Has laboratory abnormalities during the screening period.

Where this trial is running

Birmingham, Alabama and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisCrohn's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.