A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Recruiting · NCT06581328 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 32 US states.
- Gastro Health - Birmingham, Alabama, United States
- Gastro Health - Birmingham, Alabama, United States
- East View Medical Research - Mobile, Alabama, United States
- East View Medical Research - Mobile, Alabama, United States
- AZ Gastro Care - Chandler, Arizona, United States
- AZ Gastro Care - Chandler, Arizona, United States
- Spectrum Research Institute LLC - Gilbert, Arizona, United States
- Spectrum Research Institute LLC - Gilbert, Arizona, United States
- GI Alliance- Sun City - Sun City, Arizona, United States
- GI Alliance- Sun City - Sun City, Arizona, United States
- UAMS Health Gastroenterology Clinic - Little Rock, Arkansas, United States
- UAMS Health Gastroenterology Clinic - Little Rock, Arkansas, United States
- Gastroenterology and Liver Institute - Escondido, California, 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
- Inland Empire Gastroenterology - Murrieta, California, United States
- United Clinical Research Institute - Murrieta, California, United States
- Digestive Health Institute - Newport Beach, California, United States
- Digestive Health Institute - Newport Beach, California, United States
- Knowledge Research Center - Orange, California, United States
- Knowledge Research Center - Orange, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Rocky Mountain Endocopy Centers LLC - Littleton, Colorado, United States
- Rocky Mountain Endocopy Centers LLC - Littleton, Colorado, United States
- Access Research Institute - Brooksville, Florida, United States
- Access Research Institute - Brooksville, Florida, United States
- Gastro Florida - Clearwater, Florida, United States
- Gastro Florida - Clearwater, Florida, United States
- Doral Medical Research, LLC - Hialeah, Florida, United States
- Doral Medical Research, LLC - Hialeah, Florida, United States
- Digestive and Liver Center of Florida, P.A. - Kissimmee, Florida, United States
- Digestive and Liver Center of Florida, P.A. - Kissimmee, Florida, United States
- Gastro Health Research - Miami - Miami, Florida, United States
- Gastro Health Research - Miami - Miami, Florida, United States
- The Clinical Trials Network CTNX LLC - Orange City, 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
- 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
- Gastro Health Research - Pensacola - Pensacola, Florida, United States
- West Central Gastroenterology d/b/a Gastro Florida - Pinellas Park, 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
- 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
- Atlanta Center for Gastroenterology, P.C. - Decatur, Georgia, United States
- Yapp, Rockford M.D. (Private Practice) - Downers Grove, Illinois, United States
- Yapp, Rockford M.D. (Private Practice) - Downers Grove, Illinois, United States
- GI Alliance - Glenview - Glenview, Illinois, United States
- GI Alliance - Glenview - Glenview, Illinois, United States
Showing 60 of 202 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →