Under construction – not a live service
Sign in
Taking people in United StatesPhase 4

Tests vedolizumab in adults with ulcerative colitis or Crohn's disease

Tests vedolizumab, given by vein then under the skin, in adults with gut inflammation.

Plain-language title generated from the registry record
Registry title: A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting

Key facts

Where
Albuquerque, Atlanta, Baton Rouge, Bellevue, Birmingham, Bridgeton, Brooksville, Carmel, Cedarhurst, Chandler, Charlotte, Chevy Chase, Cincinnati, Clearwater, Colorado Springs, Columbia, Crestview Hills, Dayton, Decatur, Downers Grove, El Paso, Elmhurst, Escondido, Framingham, Fresh Meadows, Georgetown, Gilbert, Glen Burnie, Glenview, Greenville, Hialeah, Houston, Hutchinson, Kansas City, Katy, Kingsport, Kingwood, Kissimmee, Lafayette, Lake Barrington, Lake Success, Liberty Township, Little Rock, Littleton, Lubbock, Mentor, Metairie, Miami, Mobile, Murrieta, Naperville, New Bedford, New York, Newport Beach, Oak Lawn, Ogden, Orange, Orlando, Pensacola, Pinehurst, Pinellas Park, Plymouth, Portland, Providence, Reno, Roanoke, Rochester, Rockford, San Diego, Seaford, Sioux Falls, Southaven, Springboro, Springfield, Statesville, Suffolk, Summerville, Sun City, Syracuse, Tomball, Utica, Waco, Webster, Weldon Spring, West Nyack, Westfield, Westlake, Williamsburg, Wilmington, Wyoming, and Ypsilanti, United StatesSee the 101 sites
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06581328, who can take part

Where in United States

  • Presbyterian Health care servicesAlbuquerque, United StatesNo longer taking part
  • AGA GA Research LLCAtlanta, United StatesTaking people
  • Digestive Healthcare of GeorgiaAtlanta, United StatesTaking people
  • Baton Rouge General Medical Center - Bluebonnet CampusBaton Rouge, United StatesTaking people
  • GI AllianceBellevue, United StatesTaking people
  • Gastro HealthBirmingham, United StatesTaking people
  • SSM Health Medical GroupBridgeton, United StatesTaking people
  • Access Research InstituteBrooksville, United StatesTaking people
  • Westchester Putnam Gastroenterology PCCarmel, United StatesTaking people
  • Five Towns GastroenterologyCedarhurst, United StatesTaking people
  • AZ Gastro CareChandler, United StatesTaking people
  • Charlotte Gastroenterology and Hepatology, P.L.L.CCharlotte, United StatesTaking people
  • Capital Digestive CareChevy Chase, United StatesTaking people
  • Gastro Health Research - CincinnatiCincinnati, United StatesTaking people
  • Gastro FloridaClearwater, United StatesTaking people
  • Peak Gastroenterology AssociatesColorado Springs, United StatesTaking people
  • GI Associates Research, LLCColumbia, United StatesTaking people
  • Tri-State Gastroenterology AssociatesCrestview Hills, United StatesTaking people
  • DSI Research Northridge LLCDayton, United StatesTaking people
  • Atlanta Center For Gastroenterology, P.C.Decatur, United StatesNo longer taking part
  • Yapp, Rockford M.D. (Private Practice)Downers Grove, United StatesTaking people
  • The Clinical Trials Network CTNX LLCEl Paso, United StatesTaking people
  • IMIDeologyElmhurst, United StatesTaking people
  • Gastroenterology and Liver InstituteEscondido, United StatesTaking people
  • Gastro Health Research - FraminghamFramingham, United StatesTaking people
  • Intercity GastroenterologyFresh Meadows, United StatesTaking people
  • Amel Med LLCGeorgetown, United StatesTaking people
  • Spectrum Research Institute LLCGilbert, United StatesTaking people
  • Woodholme GastroenterologyGlen Burnie, United StatesTaking people
  • GI Alliance GlenviewGlenview, United StatesTaking people
  • Carolina Digestive DiseasesGreenville, United StatesTaking people
  • Doral Medical Research, LLCHialeah, United StatesNo longer taking part
  • Kelsey Research FoundationHouston, United StatesTaking people
  • MedCare Pharma LLCHouston, United StatesTaking people
  • Spring Clinical ResearchHouston, United StatesTaking people
  • Integrity Advanced TherapeuticsHouston, United StatesNo longer taking part
  • Hutchinson ClinicHutchinson, United StatesTaking people
  • Mid-America Gastro-Intestinal ConsultantsKansas City, United StatesTaking people
  • Gastro Health & NutritionKaty, United StatesTaking people
  • Tri-Cities GastroenterologyKingsport, United StatesTaking people
  • One of a Kind Clinical Research Center LLCKingwood, United StatesTaking people
  • Digestive and Liver Center of Florida, P.A.Kissimmee, United StatesTaking people
  • Combined Gastro LLCLafayette, United StatesTaking people
  • Gastroenterology and Internal Medicine Specialists, SCLake Barrington, United StatesTaking people
  • NYU Langone Long Island Clinical Research AssociatesLake Success, United StatesNo longer taking part
  • Gastro Health Research - Liberty TownshipLiberty Township, United StatesTaking people
  • UAMS Health Gastroenterology ClinicLittle Rock, United StatesNo longer taking part
  • Rocky Mountain Endocopy Centers LLCLittleton, United StatesTaking people
  • West Texas Research InstituteLubbock, United StatesTaking people
  • Great Lakes Gastroenterology Research, LLCMentor, United StatesTaking people
  • GI AllianceMetairie, United StatesTaking people
  • Gastro Health Research - MiamiMiami, United StatesTaking people
  • East View Medical ResearchMobile, United StatesTaking people
  • United Clinical Research InstituteMurrieta, United StatesTaking people
  • Inland Empire GastroenterologyMurrieta, United StatesNo longer taking part
  • Suburban GastroenterologyNaperville, United StatesNo longer taking part
  • Lucida Clinical Trials, LLCNew Bedford, United StatesTaking people
  • New York Gastroenterology AssociatesNew York, United StatesTaking people
  • Lenox Hill HospitalNew York, United StatesNo longer taking part
  • Manhattan Clinical Research, LLCNew York, United StatesNo longer taking part
  • Digestive Health InstituteNewport Beach, United StatesNo longer taking part
  • GI Partners of Illinois - Southwest GastroenterologyOak Lawn, United StatesTaking people
  • Advanced Research InstituteOgden, United StatesNo longer taking part
  • Knowledge Research CenterOrange, United StatesNo longer taking part
  • Endoscopic Research, IncOrlando, United StatesTaking people
  • Orlando Health Orlando Regional Medical CenterOrlando, United StatesTaking people
  • Digestive and Liver Center of FloridaOrlando, United StatesNo longer taking part
  • Gastro Health Research - PensacolaPensacola, United StatesTaking people
  • Pinehurst Medical Clinic IncPinehurst, United StatesNo longer taking part
  • West Central Gastroenterology d/b/a Gastro FloridaPinellas Park, United StatesTaking people
  • MNGI Digestive Health, P.A.Plymouth, United StatesNo longer taking part
  • Portland Gastroenterology CenterPortland, United StatesTaking people
  • The Oregon Clinic, P.C.Portland, United StatesTaking people
  • University GastroenterologyProvidence, United StatesTaking people
  • Advanced Research InstituteReno, United StatesNo longer taking part
  • Gastroenterology Consultants of Southwest VirginiaRoanoke, United StatesTaking people
  • Gastroenterology Group of RochesterRochester, United StatesNo longer taking part
  • Rockford Gastroenterology Associates, Ltd.Rockford, United StatesTaking people
  • Medical Associates Research Group, Inc.San Diego, United StatesNo longer taking part
  • ProHealth (Seaford) (Optum)Seaford, United StatesTaking people
  • Sanford Center for Digestive HealthSioux Falls, United StatesTaking people
  • Delta Gastroenterology and Endoscopy CenterSouthaven, United StatesTaking people
  • DSI Research, LLCSpringboro, United StatesTaking people
  • Springfield ClinicSpringfield, United StatesTaking people
  • Piedmont HealthcareStatesville, United StatesTaking people
  • Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute ResearchSuffolk, United StatesNo longer taking part
  • Palmetto Primary Care Physician Division of GastroenterologySummerville, United StatesTaking people
  • GI Alliance Sun CitySun City, United StatesTaking people
  • Syracuse VA Medical CenterSyracuse, United StatesNo longer taking part
  • Texas Gastro ConsultantsTomball, United StatesNo longer taking part
  • Digestive Disease MedicineUtica, United StatesTaking people
  • Digestive Research of Central Texas, LLCWaco, United StatesTaking people
  • GI Alliance WebsterWebster, United StatesTaking people
  • St. Charles Clinical ResearchWeldon Spring, United StatesTaking people
  • Crystal Run (Optum)West Nyack, United StatesTaking people
  • Riverview HealthWestfield, United StatesTaking people
  • Northshore Gastroenterology Research, LLCWestlake, United StatesTaking people
  • TMPG Clinical ResearchWilliamsburg, United StatesNo longer taking part
  • Wilmington Gastroenterology AssociatesWilmington, United StatesTaking people
  • Gastroenterology Associates of Western Michigan, P.L.C.Wyoming, United StatesTaking people
  • Huron GastroYpsilanti, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Takeda
Trial code
NCT06581328
Record updated
28 October 2026
Original description
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).Read full original descriptionShow less

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

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.

Inclusion: To be eligible to participate in this study, participants must meet all the following criteria:; In the investigator's opinion, the participant can understand and comply with protocol requirements; The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures; The participant is 18 to 80 years of age at the time of signing the ICF; The participant's immunization is up to date per vedolizumab US prescribing information (USPI); Participants must meet the contraception recommendations; The participant has a diagnosis of moderate to severely active UC or CD defined by the following:; 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; UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening; UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report; 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: Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening; Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments; Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD); Received any investigational biologic therapy <= 6 months prior to screening; The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening; Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators; A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period; Participant is not on a stable dose of corticosteroid; 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 a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients; The participant has any evidence of an active infection during screening; Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome; Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety; Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease; Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin <8 grams per deciliter (g/dL); (b) white blood cell (WBC) count <3.0 × 10\^9 per liter (L); (c) lymphocyte count <0.5 × 10\^9/L; (d) platelet count <100 × 10\^9/L or >1200 × 10\^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) >1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening; History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment; Participants who meet any of the following exclusion criteria will be excluded from participation in this study:.

ClinicalTrials.gov NCT06581328