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RECRUITING

NCT06581328

PHASE4

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-03-27

Completion Date

2028-06-01

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Ulcerative Colitis Crohn's Disease

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV infusion

DRUG

Vedolizumab SC

Vedolizumab SC injection

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.

Locations (94)

Gastro Health Research- St. Vincents East

Birmingham, Alabama, United States

East View Medical Research

Mobile, Alabama, United States

AZ Gastro Care

Chandler, Arizona, 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

United Clinical Research Institute

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

West Central Gastroenterology d/b/a Gastro Florida

Pinellas Park, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

AGA GA Research 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

Springfield Clinic

Springfield, Illinois, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Baton Rouge General Medical Center - Bluebonnet Campus

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

Five Towns Gastroenterology

Cedarhurst, 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

Digestive Disease Medicine

Utica, 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

MedCare Pharma LLC

Houston, Texas, United States

Integrity Advanced Therapeutics

Houston, Texas, United States

Spring Clinical Research

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

Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research

Suffolk, Virginia, United States

TMPG Clinical Research

Williamsburg, Virginia, United States

GI Alliance

Bellevue, Washington, United States

Clinical Research Directory

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (94)