A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
NCT ID: NCT06581328
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
400 participants
INTERVENTIONAL
2025-03-27
2028-06-01
Brief Summary
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Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.
During the study, participants will visit their study clinic several times.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UC Participants: Vedolizumab
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Vedolizumab IV
Vedolizumab IV infusion
Vedolizumab SC
Vedolizumab SC injection
CD Participants: Vedolizumab
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Vedolizumab IV
Vedolizumab IV infusion
Vedolizumab SC
Vedolizumab SC injection
Interventions
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Vedolizumab IV
Vedolizumab IV infusion
Vedolizumab SC
Vedolizumab SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
18 Years
80 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Gastro Health Research- St. Vincents East
Birmingham, Alabama, United States
East View Medical Research
Mobile, Alabama, United States
Spectrum Research Institute LLC
Gilbert, Arizona, United States
GI Alliance- Sun City
Sun City, Arizona, United States
UAMS Health Gastroenterology Clinic
Little Rock, Arkansas, United States
Gastroenterology and Liver Institute
Escondido, California, United States
Inland Empire Gastroenterology
Murrieta, California, United States
Digestive Health Institute
Newport Beach, California, United States
Knowledge Research Center
Orange, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Associates in Gastroenterology, PC
Colorado Springs, Colorado, United States
Rocky Mountain Endocopy Centers LLC
Littleton, Colorado, United States
Access Research Institute
Brooksville, Florida, United States
Gastro Florida
Clearwater, Florida, United States
Doral Medical Research, LLC
Hialeah, Florida, United States
Digestive and Liver Center of Florida, P.A.
Kissimmee, Florida, United States
Gastro Health Research - Miami
Miami, Florida, United States
The Clinical Trials Network CTNX LLC
Orange City, Florida, United States
Endoscopic Research, Inc.
Orlando, Florida, United States
Orlando Health-Orlando Regional Medical Center
Orlando, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Gastro Health Research - Pensacola
Pensacola, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates LLC
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
Yapp, Rockford M.D. (Private Practice)
Downers Grove, Illinois, United States
GI Alliance - Glenview
Glenview, Illinois, United States
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington, Illinois, United States
Suburban Gastroenterology
Naperville, Illinois, United States
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
GI Alliance
Metairie, Louisiana, United States
Portland Gastroenterology Center
Portland, Maine, United States
Capital Digestive Care
Chevy Chase, Maryland, United States
Woodholme Gastroenterology
Glen Burnie, Maryland, United States
Gastro Health Research - Framingham
Framingham, Massachusetts, United States
Lucida Clinical Trials LLC
New Bedford, Massachusetts, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
Huron Gastro
Ypsilanti, Michigan, United States
MNGI Digestive Health, P.A.
Plymouth, Minnesota, United States
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, United States
GI Associates Research, LLC
Columbia, Missouri, United States
Mid America Gastro Intestinal Consultants
Kansas City, Missouri, United States
St Charles Clinical Research
Weldon Spring, Missouri, United States
Advanced Research Institute
Reno, Nevada, United States
Presbyterian Health care services
Albuquerque, New Mexico, United States
Westchester Putnam Gastroenterology PC
Carmel, New York, United States
IMIDeology
Elmhurst, New York, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States
Lenox Hill Hospital
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Manhattan Clinical Research, LLC
New York, New York, United States
Gastroenterology Group of Rochester
Rochester, New York, United States
ProHealth (Seaford) (Optum)
Seaford, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, United States
Piedmont Healthcare
Statesville, North Carolina, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States
Gastro Health Research - Cincinnati
Cincinnati, Ohio, United States
DSI Research Northridge LLC
Dayton, Ohio, United States
Gastro Health Research - Liberty Township
Liberty Township, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
DSI Research LLC
Springboro, Ohio, United States
NorthShore Gastroenterology Research, LLC
Westlake, Ohio, United States
The Oregon Clinic, P.C.
Portland, Oregon, United States
University Gastroenterology
Providence, Rhode Island, United States
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, United States
The Clinical Trials Network CTNX LLC
El Paso, Texas, United States
Amel Med LLC
Georgetown, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
Integrity Advanced Therapeutics
Houston, Texas, United States
One of a Kind Clinical Research Center LLC
Kingwood, Texas, United States
West Texas Research Institute
Lubbock, Texas, United States
Texas Gastro Consultants
Tomball, Texas, United States
Digestive Research of Central Texas, LLC
Waco, Texas, United States
GI Alliance - Webster
Webster, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia, United States
TMPG Clinical Research
Williamsburg, Virginia, United States
GI Alliance
Bellevue, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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Vedolizumab-4063
Identifier Type: -
Identifier Source: org_study_id
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