A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
PANORAMA
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
1 other identifier
interventional
400
1 country
100
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2025
Typical duration for phase_4
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 10, 2026
June 1, 2026
2.5 years
August 30, 2024
June 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
At Week 14
Percentage of UC Participants With PRO-2 Remission at Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
At Week 14
Secondary Outcomes (11)
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
At Weeks 6 and 52
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52
At Weeks 6, 14, and 52
Percentage of CD Participants With Endoscopic Response at Week 52
At Week 52
Percentage of CD Participants Achieving Endoscopic Remission at Week 52
At Week 52
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
At Week 52
- +6 more secondary outcomes
Study Arms (2)
UC Participants: Vedolizumab
EXPERIMENTALParticipants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
CD Participants: Vedolizumab
EXPERIMENTALParticipants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Interventions
Vedolizumab SC injection
Vedolizumab IV infusion
Eligibility Criteria
You may qualify if:
- 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).
- If participant is a woman of childbearing potential (WOCBP):
- 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.
- 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.
- Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
- Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
- If participant is a fertile man:
- Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
- Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.
- 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
- +3 more criteria
You may not qualify if:
- 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 (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).
- 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. 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).
- 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 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.
- 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.
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.
- Has laboratory abnormalities during the screening period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (100)
Gastro Health Research- St. Vincents East
Birmingham, Alabama, 35235, 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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
March 27, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.