A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Takeda · NCT06581328
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 200
- US sites recruiting
- 78
- Study start
- March 27, 2025
- Record last updated
- October 20, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Vedolizumab IV; Vedolizumab SC
Conditions: Ulcerative Colitis; Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
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 Criteria
Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
- 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).
- 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.
- 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.
a. Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators.
- The participant has any evidence of an active infection during screening.
- Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome.
- A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period.
- 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 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.
- Participant is not on a stable dose of corticosteroid.
- 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.
Recruiting US locations
Gastro Health
Birmingham, AL 35243
Site contact: Site Contact · 205-838-3823 · rshaffer@gastrohealth.com
East View Medical Research
Mobile, AL 36608
Site contact: Site Contact · 251-277-9090 · jdsiegelmd@gmail.com
AZ Gastro Care
Chandler, AZ 85225
Site contact: Site Contact · 480-393-0575 · squreshi@azgastrocare.com
Spectrum Research Institute LLC
Gilbert, AZ 85297
Site contact: Site Contact · 480-801-9260 · donnad@sevalleygi.com
GI Alliance- Sun City
Sun City, AZ 85351
Site contact: Site Contact · 623-972-2116 · ctrivedipi@arizonadigestivehealth.com
Gastroenterology and Liver Institute
Escondido, CA 92025
Site contact: Site Contact · 808-469-0575 · drgara@giandliver.org
United Clinical Research Institute
Murrieta, CA 92563
Site contact: Site Contact · 951-566-5229 · drhongpi@unitedmd.com
Peak Gastroenterology Associates
Colorado Springs, CO 80907
Site contact: Site Contact · 719-310-6719 · bpatel@peakgastro.com
Rocky Mountain Endocopy Centers LLC
Littleton, CO 80120
Site contact: Site Contact · 303-722-8987 · rmg@fomatmedical.com
Access Research Institute
Brooksville, FL 34613
Site contact: Site Contact · 352-691-1140 · s.muddassir@ariinstitute.com
Gastro Florida
Clearwater, FL 33762
Site contact: Site Contact · 727-336-7682 · lmweiss@gastrofl.com
Digestive and Liver Center of Florida, P.A.
Kissimmee, FL 34741
Site contact: Site Contact · 407-384-7388 · batiquzzaman@crosceola.com
Gastro Health Research - Miami
Miami, FL 33176
Site contact: Site Contact · 786-539-3215 · jlopez@gastrohealth.com
Endoscopic Research, Inc.
Orlando, FL 32803
Site contact: Site Contact · 407-896-1726 · ilaganeri@cdhfl.com
Orlando Health-Orlando Regional Medical Center
Orlando, FL 32806
Site contact: Site Contact · 321-842-7900 · udayakumar.navaneethan@orlandohealth.com
Gastro Health Research - Pensacola
Pensacola, FL 32504
Site contact: Site Contact · 850-436-4536 · fnewman@gastrohealth.com
West Central Gastroenterology d/b/a Gastro Florida
Pinellas Park, FL 33781
Site contact: Site Contact · 727-347-0005 · tglamour@gastrofl.com
Digestive Healthcare of Georgia
Atlanta, GA 30327
Site contact: Site Contact · 404-355-3200 · mgalambos@yahoo.com
AGA GA Research LLC
Atlanta, GA 30342
Site contact: Site Contact · 404-257-9000 · brett.mendel@atlantagastro.com
Yapp, Rockford M.D. (Private Practice)
Downers Grove, IL 60515
Site contact: Site Contact · 859-999-4506 · rgjsy34@aol.com
GI Alliance - Glenview
Glenview, IL 60026
Site contact: Site Contact · 847-677-1170 · nmerel@illinoisgastro.com
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington, IL 60010
Site contact: Site Contact · 708-560-7299 · drbhuva@avicennaclinical.com
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn, IL 60453
Site contact: Site Contact · 708-253-5810 · drberkelhammer@avicennaclinical.com
Rockford Gastroenterology Associates, Ltd.
Rockford, IL 61107
Site contact: Site Contact · 815-397-7340 · drpatel@rockfordgi.com
Springfield Clinic
Springfield, IL 62703
Site contact: Site Contact · 217-528-7541 · dshuster@springfieldclinic.com
Riverview Health
Westfield, IN 46074
Site contact: Site Contact · 317-948-3369 · sashidharvarma@yahoo.com
Hutchinson Clinic
Hutchinson, KS 67502
Site contact: Site Contact · 620-669-2500 · greenm@hutchclinic.com
Tri-State Gastroenterology Associates
Crestview Hills, KY 41017
Site contact: Site Contact · 859-341-3575 · mjones-research@tsddc.com
Baton Rouge General Medical Center - Bluebonnet Campus
Baton Rouge, LA 70809
Site contact: Site Contact · 225-763-4828 · cchapman@tddctx.com
Combined Gastro LLC
Lafayette, LA 70503
Site contact: Site Contact · 337-235-9779 · jacque@gastroclinic.com
GI Alliance
Metairie, LA 70006
Site contact: Site Contact · 504-456-8020 · catinis@metrogi.com
Portland Gastroenterology Center
Portland, ME 04101
Site contact: Site Contact · 207-773-7964 · noemi.baffy@portlandgastro.com
Capital Digestive Care
Chevy Chase, MD 20815
Site contact: Site Contact · 301-841-6869 · erica.cohen@capitaldigestivecare.com
Woodholme Gastroenterology
Glen Burnie, MD 21061
Site contact: Site Contact · 410-783-8441 · konwueme@fomatmedical.com
Gastro Health Research - Framingham
Framingham, MA 01702
Site contact: Site Contact · 508-620-9200 · sfine@gastrohealth.com
Lucida Clinical Trials LLC
New Bedford, MA 02740
Site contact: Site Contact · 508-720-2015 · jreich@lucidaclinical.com
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, MI 49519
Site contact: Site Contact · 616-328-5344 · acoates@gastro-assoc-wm.com
Huron Gastro
Ypsilanti, MI 48197
Site contact: Site Contact · 734-418-7736 · soofin@hurongastro.com
Delta Gastroenterology and Endoscopy Center
Southaven, MS 38671
Site contact: Site Contact · 662-280-8222 · uduncan@deltagastro.net
SSM Health Medical Group
Bridgeton, MO 63044
Site contact: Site Contact · 314-291-8824 · yezaz.ghouri@ssmhealth.com
GI Associates Research, LLC
Columbia, MO 65201
Site contact: Site Contact · 573-740-0800 · michael.williams@objective.health
Mid America Gastro Intestinal Consultants
Kansas City, MO 64111
Site contact: Site Contact · 888-635-0552 · hillarybownik@cctdoctors.com
St Charles Clinical Research
Weldon Spring, MO 63304
Site contact: Site Contact · 314-567-3377 · lw@gidoctor.net
Westchester Putnam Gastroenterology PC
Carmel, NY 10512
Site contact: Site Contact · 845-278-5223 · rperinbasekar@putnamgi.com
Five Towns Gastroenterology
Cedarhurst, NY 11516
Site contact: Site Contact · 516-374-5570 · marctfenster@gmail.com
IMIDeology
Elmhurst, NY 11373
Site contact: Site Contact · 929-374-4054 · kevintin@yahoo.com
Intercity Gastroenterology
Fresh Meadows, NY 11040
Site contact: Site Contact · 929-405-0165 · g.shahzad@synapsetrial.com
New York Gastroenterology Associates
New York, NY 10075
Site contact: Site Contact · 917-855-1993 · ana.tuyama@nygahealth.com
ProHealth (Seaford) (Optum)
Seaford, NY 11783
Site contact: Site Contact · 516-796-9000 · cserer@prohealthcare.com
Digestive Disease Medicine
Utica, NY 13502
Site contact: Site Contact · 315-624-7000 · harvey.allen@kinstonmd.com
Crystal Run (Optum)
West Nyack, NY 10994
Site contact: Site Contact · 845-703-3964 · thaider@crystalrunhealthcare.com
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, NC 28207
Site contact: Site Contact · 704-375-9485 · gardiner.roddey@charlottegastro.com
Carolina Digestive Diseases
Greenville, NC 27834
Site contact: Site Contact · 252-758-8181 · pgoldstein@cddgastro.com
Piedmont Healthcare
Statesville, NC 28625
Site contact: Site Contact · 404-605-2632 · brandon.marion@piedmonthealthcare.com
Wilmington Gastroenterology Associates
Wilmington, NC 28403
Site contact: Site Contact · 910-362-1011 · wking@trialmgt.com
Gastro Health Research - Cincinnati
Cincinnati, OH 45219
Site contact: Site Contact · 513-682-2892 · matkinson@gastrohealth.com
DSI Research Northridge LLC
Dayton, OH 45414
Site contact: Site Contact · 937-469-8047 · rajeev.kurapati@objective.health
Gastro Health Research - Liberty Township
Liberty Township, OH 45044
Site contact: Site Contact · 513-872-4549 · smartin@gastrohealth.com
Great Lakes Gastroenterology Research, LLC
Mentor, OH 44060
Site contact: Site Contact · 440-205-1225 · kfriedenberg@thectnx.com
DSI Research LLC
Springboro, OH 45066
Site contact: Site Contact · 937-293-2169 · anjali.morey@objective.health
+ 18 more on the official record.
Study contacts (from the official record)
- Takeda Contact · +1-877-825-3327 · medinfoUS@takeda.com