RecruitingRecruiting
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
NCT06581328 · Takeda
In plain English
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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
About this study
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
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. Participants must meet the contraception recommendations.
6. 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 sub-score of 2 to 3 at screening.
7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
8. 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 a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients.
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 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.
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 30 days prior to screening or planned or possible major surgery during the study period.
10. 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.
11. 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.
12. 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.
13. Participant is not on a stable dose of corticosteroid.
14. 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.
Study design
Enrollment target: 200 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-27
Estimated completion: 2028-06-01
Last updated: 2026-09-15
Interventions
Drug: Vedolizumab IVDrug: Vedolizumab SC
Primary outcomes
- • Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14 (At Week 14)
- • Percentage of UC Participants With PRO-2 Remission at Week 14 (At Week 14)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (101)
Gastro HealthRecruiting
Birmingham, Alabama, United States
East View Medical ResearchRecruiting
Mobile, Alabama, United States
AZ Gastro CareRecruiting
Chandler, Arizona, United States
Spectrum Research Institute LLCRecruiting
Gilbert, Arizona, United States
GI Alliance- Sun CityRecruiting
Sun City, Arizona, United States
UAMS Health Gastroenterology ClinicWithdrawn
Little Rock, Arkansas, United States
Gastroenterology and Liver InstituteRecruiting
Escondido, California, United States
Inland Empire GastroenterologyWithdrawn
Murrieta, California, United States
United Clinical Research InstituteRecruiting
Murrieta, California, United States
Digestive Health InstituteWithdrawn
Newport Beach, California, United States
Knowledge Research CenterWithdrawn
Orange, California, United States
Medical Associates Research Group, Inc.Withdrawn
San Diego, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Rocky Mountain Endocopy Centers LLCRecruiting
Littleton, Colorado, United States
Access Research InstituteRecruiting
Brooksville, Florida, United States
Gastro FloridaRecruiting
Clearwater, Florida, United States
Doral Medical Research, LLCWithdrawn
Hialeah, Florida, United States
Digestive and Liver Center of Florida, P.A.Recruiting
Kissimmee, Florida, United States
Gastro Health Research - MiamiRecruiting
Miami, Florida, United States
The Clinical Trials Network CTNX LLCRecruiting
Orange City, Florida, United States
Endoscopic Research, Inc.Recruiting
Orlando, Florida, United States
Orlando Health-Orlando Regional Medical CenterRecruiting
Orlando, Florida, United States
Digestive and Liver Center of FloridaWithdrawn
Orlando, Florida, United States
Gastro Health Research - PensacolaRecruiting
Pensacola, Florida, United States
West Central Gastroenterology d/b/a Gastro FloridaRecruiting
Pinellas Park, Florida, United States
Digestive Healthcare of GeorgiaRecruiting
Atlanta, Georgia, United States
AGA GA Research LLCRecruiting
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology, P.C.Withdrawn
Decatur, Georgia, United States
Yapp, Rockford M.D. (Private Practice)Recruiting
Downers Grove, Illinois, United States
GI Alliance - GlenviewRecruiting
Glenview, Illinois, United States
Gastroenterology and Internal Medicine Specialists, SCRecruiting
Lake Barrington, Illinois, United States
Suburban GastroenterologyWithdrawn
Naperville, Illinois, United States
GI Partners of Illinois - Southwest GastroenterologyRecruiting
Oak Lawn, Illinois, United States
Rockford Gastroenterology Associates, Ltd.Recruiting
Rockford, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Hutchinson ClinicRecruiting
Hutchinson, Kansas, United States
Tri-State Gastroenterology AssociatesRecruiting
Crestview Hills, Kentucky, United States
Baton Rouge General Medical Center - Bluebonnet CampusRecruiting
Baton Rouge, Louisiana, United States
Combined Gastro LLCRecruiting
Lafayette, Louisiana, United States
GI AllianceRecruiting
Metairie, Louisiana, United States
Portland Gastroenterology CenterRecruiting
Portland, Maine, United States
Capital Digestive CareRecruiting
Chevy Chase, Maryland, United States
Woodholme GastroenterologyRecruiting
Glen Burnie, Maryland, United States
Gastro Health Research - FraminghamRecruiting
Framingham, Massachusetts, United States
Lucida Clinical Trials LLCRecruiting
New Bedford, Massachusetts, United States
Gastroenterology Associates of Western Michigan, P.L.C.Recruiting
Wyoming, Michigan, United States
Huron GastroRecruiting
Ypsilanti, Michigan, United States
MNGI Digestive Health, P.A.Withdrawn
Plymouth, Minnesota, United States
Delta Gastroenterology and Endoscopy CenterRecruiting
Southaven, Mississippi, United States
SSM Health Medical GroupRecruiting
Bridgeton, Missouri, United States
GI Associates Research, LLCRecruiting
Columbia, Missouri, United States
Mid America Gastro Intestinal ConsultantsRecruiting
Kansas City, Missouri, United States
St Charles Clinical ResearchRecruiting
Weldon Spring, Missouri, United States
Advanced Research InstituteWithdrawn
Reno, Nevada, United States
Presbyterian Health care servicesWithdrawn
Albuquerque, New Mexico, United States
Westchester Putnam Gastroenterology PCRecruiting
Carmel, New York, United States
Five Towns GastroenterologyRecruiting
Cedarhurst, New York, United States
IMIDeologyRecruiting
Elmhurst, New York, United States
Intercity GastroenterologyRecruiting
Fresh Meadows, New York, United States
NYU Langone Long Island Clinical Research AssociatesWithdrawn
Lake Success, New York, United States
Lenox Hill HospitalWithdrawn
New York, New York, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Manhattan Clinical Research, LLCWithdrawn
New York, New York, United States
Gastroenterology Group of RochesterWithdrawn
Rochester, New York, United States
ProHealth (Seaford) (Optum)Recruiting
Seaford, New York, United States
Syracuse VA Medical CenterWithdrawn
Syracuse, New York, United States
Digestive Disease MedicineRecruiting
Utica, New York, United States
Crystal Run (Optum)Recruiting
West Nyack, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.CRecruiting
Charlotte, North Carolina, United States
Carolina Digestive DiseasesRecruiting
Greenville, North Carolina, United States
Pinehurst Medical Clinic IncWithdrawn
Pinehurst, North Carolina, United States
Piedmont HealthcareRecruiting
Statesville, North Carolina, United States
Wilmington Gastroenterology AssociatesRecruiting
Wilmington, North Carolina, United States
Gastro Health Research - CincinnatiRecruiting
Cincinnati, Ohio, United States
DSI Research Northridge LLCRecruiting
Dayton, Ohio, United States
Gastro Health Research - Liberty TownshipRecruiting
Liberty Township, Ohio, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
DSI Research LLCRecruiting
Springboro, Ohio, United States
NorthShore Gastroenterology Research, LLCRecruiting
Westlake, Ohio, United States
The Oregon Clinic, P.C.Recruiting
Portland, Oregon, United States
University GastroenterologyRecruiting
Providence, Rhode Island, United States
Palmetto Primary Care Physician Division of GastroenterologyRecruiting
Summerville, South Carolina, United States
Sanford Center for Digestive HealthRecruiting
Sioux Falls, South Dakota, United States
Tri-Cities GastroenterologyRecruiting
Kingsport, Tennessee, United States
The Clinical Trials Network CTNX LLCRecruiting
El Paso, Texas, United States
Amel Med LLCRecruiting
Georgetown, Texas, United States
Kelsey Research FoundationRecruiting
Houston, Texas, United States
MedCare Pharma LLCRecruiting
Houston, Texas, United States
Integrity Advanced TherapeuticsWithdrawn
Houston, Texas, United States
Spring Clinical ResearchRecruiting
Houston, Texas, United States
Gastro Health & NutritionRecruiting
Katy, Texas, United States
One of a Kind Clinical Research Center LLCRecruiting
Kingwood, Texas, United States
West Texas Research InstituteRecruiting
Lubbock, Texas, United States
Texas Gastro ConsultantsWithdrawn
Tomball, Texas, United States
Digestive Research of Central Texas, LLCRecruiting
Waco, Texas, United States
GI Alliance - WebsterRecruiting
Webster, Texas, United States
Advanced Research InstituteWithdrawn
Ogden, Utah, United States
Gastroenterology Consultants of Southwest Virginia.Recruiting
Roanoke, Virginia, United States
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute ResearchWithdrawn
Suffolk, Virginia, United States
TMPG Clinical ResearchWithdrawn
Williamsburg, Virginia, United States
GI AllianceRecruiting
Bellevue, Washington, United States