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NCT06581328PHASE4Recruiting

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

Takeda

Start Date

3/27/2025

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Vedolizumab IV

DRUG

Vedolizumab SC

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Conditions

Ulcerative ColitisCrohn's Disease

Locations

Gastro Health

Birmingham, Alabama 35243

United States

East View Medical Research

Mobile, Alabama 36608

United States

AZ Gastro Care

Chandler, Arizona 85225

United States

Spectrum Research Institute LLC

Gilbert, Arizona 85297

United States

GI Alliance- Sun City

Sun City, Arizona 85351

United States

UAMS Health Gastroenterology Clinic

Little Rock, Arkansas 72205

United States

Gastroenterology and Liver Institute

Escondido, California 92025

United States

Inland Empire Gastroenterology

Murrieta, California 92562

United States

United Clinical Research Institute

Murrieta, California 92563

United States

Digestive Health Institute

Newport Beach, California 92663

United States

Knowledge Research Center

Orange, California 92868

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Associates in Gastroenterology, PC

Colorado Springs, Colorado 80923

United States

Rocky Mountain Endocopy Centers LLC

Littleton, Colorado 80120

United States

Access Research Institute

Brooksville, Florida 34613

United States

Gastro Florida

Clearwater, Florida 33762

United States

Doral Medical Research, LLC

Hialeah, Florida 33016

United States

Digestive and Liver Center of Florida, P.A.

Kissimmee, Florida 34741

United States

Gastro Health Research - Miami

Miami, Florida 33176

United States

The Clinical Trials Network CTNX LLC

Orange City, Florida 32763

United States

Endoscopic Research, Inc.

Orlando, Florida 32803

United States

Orlando Health-Orlando Regional Medical Center

Orlando, Florida 32806

United States

Digestive and Liver Center of Florida

Orlando, Florida 32825

United States

Gastro Health Research - Pensacola

Pensacola, Florida 32504

United States

West Central Gastroenterology d/b/a Gastro Florida

Pinellas Park, Florida 33781

United States

Digestive Healthcare of Georgia

Atlanta, Georgia 30327

United States

AGA GA Research LLC

Atlanta, Georgia 30342

United States

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia 30033

United States

Yapp, Rockford M.D. (Private Practice)

Downers Grove, Illinois 60515

United States

GI Alliance - Glenview

Glenview, Illinois 60026

United States

Gastroenterology and Internal Medicine Specialists, SC

Lake Barrington, Illinois 60010

United States

Suburban Gastroenterology

Naperville, Illinois 60540

United States

GI Partners of Illinois - Southwest Gastroenterology

Oak Lawn, Illinois 60453

United States

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois 61107

United States

Springfield Clinic

Springfield, Illinois 62703

United States

Hutchinson Clinic

Hutchinson, Kansas 67502

United States

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky 41017

United States

Baton Rouge General Medical Center - Bluebonnet Campus

Baton Rouge, Louisiana 70809

United States

Combined Gastro LLC

Lafayette, Louisiana 70503

United States

GI Alliance

Metairie, Louisiana 70006

United States

Portland Gastroenterology Center

Portland, Maine 04101

United States

Capital Digestive Care

Chevy Chase, Maryland 20815

United States

Woodholme Gastroenterology

Glen Burnie, Maryland 21061

United States

Gastro Health Research - Framingham

Framingham, Massachusetts 01702

United States

Lucida Clinical Trials LLC

New Bedford, Massachusetts 02740

United States

Gastroenterology Associates of Western Michigan, P.L.C.

Wyoming, Michigan 49519

United States

Huron Gastro

Ypsilanti, Michigan 48197

United States

MNGI Digestive Health, P.A.

Plymouth, Minnesota 55446

United States

Delta Gastroenterology and Endoscopy Center

Southaven, Mississippi 38671

United States

SSM Health Medical Group

Bridgeton, Missouri 63044

United States

GI Associates Research, LLC

Columbia, Missouri 65201

United States

Mid America Gastro Intestinal Consultants

Kansas City, Missouri 64111

United States

St Charles Clinical Research

Weldon Spring, Missouri 63304

United States

Advanced Research Institute

Reno, Nevada 89511

United States

Presbyterian Health care services

Albuquerque, New Mexico 87107

United States

Westchester Putnam Gastroenterology PC

Carmel, New York 10512

United States

Five Towns Gastroenterology

Cedarhurst, New York 11516

United States

IMIDeology

Elmhurst, New York 11373

United States

Intercity Gastroenterology

Fresh Meadows, New York 11040

United States

NYU Langone Long Island Clinical Research Associates

Lake Success, New York 11042

United States

Lenox Hill Hospital

New York, New York 10075

United States

New York Gastroenterology Associates

New York, New York 10075

United States

Manhattan Clinical Research, LLC

New York, New York 10279

United States

Gastroenterology Group of Rochester

Rochester, New York 14620

United States

ProHealth (Seaford) (Optum)

Seaford, New York 11783

United States

Syracuse VA Medical Center

Syracuse, New York 13210

United States

Digestive Disease Medicine

Utica, New York 13502

United States

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina 28207

United States

Carolina Digestive Diseases

Greenville, North Carolina 27834

United States

Pinehurst Medical Clinic Inc

Pinehurst, North Carolina 28374

United States

Piedmont Healthcare

Statesville, North Carolina 28625

United States

Wilmington Gastroenterology Associates

Wilmington, North Carolina 28403

United States

Gastro Health Research - Cincinnati

Cincinnati, Ohio 45219

United States

DSI Research Northridge LLC

Dayton, Ohio 45414

United States

Gastro Health Research - Liberty Township

Liberty Township, Ohio 45044

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

DSI Research LLC

Springboro, Ohio 45066

United States

NorthShore Gastroenterology Research, LLC

Westlake, Ohio 44145

United States

The Oregon Clinic, P.C.

Portland, Oregon 97220

United States

University Gastroenterology

Providence, Rhode Island 02904

United States

Palmetto Primary Care Physician Division of Gastroenterology

Summerville, South Carolina 29486

United States

Sanford Center for Digestive Health

Sioux Falls, South Dakota 57105

United States

Tri-Cities Gastroenterology

Kingsport, Tennessee 37663

United States

The Clinical Trials Network CTNX LLC

El Paso, Texas 79936

United States

Amel Med LLC

Georgetown, Texas 78628

United States

Kelsey Research Foundation

Houston, Texas 77005

United States

MedCare Pharma LLC

Houston, Texas 77079

United States

Integrity Advanced Therapeutics

Houston, Texas 77090

United States

Spring Clinical Research

Houston, Texas 77090

United States

Gastro Health & Nutrition

Katy, Texas 77494

United States

One of a Kind Clinical Research Center LLC

Kingwood, Texas 77339

United States

West Texas Research Institute

Lubbock, Texas 79424

United States

Texas Gastro Consultants

Tomball, Texas 77375

United States

Digestive Research of Central Texas, LLC

Waco, Texas 76712

United States

GI Alliance - Webster

Webster, Texas 77598

United States

Advanced Research Institute

Ogden, Utah 84405

United States

Gastroenterology Consultants of Southwest Virginia.

Roanoke, Virginia 24014

United States

Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research

Suffolk, Virginia 23435

United States

TMPG Clinical Research

Williamsburg, Virginia 23188

United States

GI Alliance

Bellevue, Washington 98405

United States