A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting (PANORAMA)

May 28, 2026 updated by: Takeda

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Active, not recruiting
        • Gastro Health Research- St. Vincents East
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • East View Medical Research
        • Principal Investigator:
          • Jonathan Siegel
        • Contact:
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • AZ Gastro Care
        • Contact:
        • Principal Investigator:
          • Shahbaz Ali Qureshi
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Spectrum Research Institute LLC
        • Principal Investigator:
          • Donna DeSantis
        • Contact:
      • Sun City, Arizona, United States, 85351
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Withdrawn
        • UAMS Health Gastroenterology Clinic
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Gastroenterology and Liver Institute
        • Principal Investigator:
          • Naveen Gara
        • Contact:
      • Murrieta, California, United States, 92562
        • Withdrawn
        • Inland Empire Gastroenterology
      • Murrieta, California, United States, 92563
        • Recruiting
        • United Clinical Research Institute
        • Principal Investigator:
          • John Hong
        • Contact:
      • Newport Beach, California, United States, 92663
        • Withdrawn
        • Digestive Health Institute
      • Orange, California, United States, 92868
        • Withdrawn
        • Knowledge Research Center
      • San Diego, California, United States, 92123
        • Withdrawn
        • Medical Associates Research Group, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
        • Principal Investigator:
          • Bhaktasharan Patel
        • Contact:
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Associates in Gastroenterology, PC
        • Contact:
        • Principal Investigator:
          • Diana Arsene
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Endocopy Centers LLC
        • Contact:
        • Principal Investigator:
          • Erik Springer
    • Florida
      • Brooksville, Florida, United States, 34613
        • Recruiting
        • Access Research Institute
        • Contact:
        • Principal Investigator:
          • Salman Muddassir
      • Clearwater, Florida, United States, 33762
        • Recruiting
        • Gastro Florida
        • Contact:
        • Principal Investigator:
          • Michael Weiss
      • Hialeah, Florida, United States, 33016
        • Withdrawn
        • Doral Medical Research, LLC
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Digestive and Liver Center of Florida, P.A.
        • Principal Investigator:
          • Basher Atiquzzaman
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • Gastro Health Research - Miami
        • Contact:
        • Principal Investigator:
          • Joanna Lopez
      • Orange City, Florida, United States, 32763
        • Recruiting
        • The Clinical Trials Network CTNX LLC
        • Principal Investigator:
          • Vishal Gupta
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Endoscopic Research, Inc.
        • Contact:
        • Principal Investigator:
          • Marlon Ilagan
      • Orlando, Florida, United States, 32825
        • Withdrawn
        • Digestive and Liver Center of Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health-Orlando Regional Medical Center
        • Principal Investigator:
          • Udayakumar Navaneethan
        • Contact:
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Gastro Health Research - Pensacola
        • Principal Investigator:
          • Frederic Newman
        • Contact:
      • Pinellas Park, Florida, United States, 33781
        • Recruiting
        • West Central Gastroenterology d/b/a Gastro Florida
        • Principal Investigator:
          • Tejinder Glamour
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Recruiting
        • Digestive Healthcare of Georgia
        • Principal Investigator:
          • Michael Galambos
        • Contact:
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30033
        • Withdrawn
        • Atlanta Center for Gastroenterology, P.C.
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Yapp, Rockford M.D. (Private Practice)
        • Principal Investigator:
          • Rockford Yapp
        • Contact:
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • GI Alliance - Glenview
        • Contact:
        • Principal Investigator:
          • Nina Merel
      • Lake Barrington, Illinois, United States, 60010
        • Recruiting
        • Gastroenterology and Internal Medicine Specialists, SC
        • Principal Investigator:
          • Manish Bhuva
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Withdrawn
        • Suburban Gastroenterology
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • GI Partners of Illinois - Southwest Gastroenterology
        • Principal Investigator:
          • Charles Berkelhammer
        • Contact:
      • Rockford, Illinois, United States, 61107
        • Recruiting
        • Rockford Gastroenterology Associates, Ltd.
        • Principal Investigator:
          • Sunil Patel
        • Contact:
      • Springfield, Illinois, United States, 62703
        • Recruiting
        • Springfield Clinic
        • Contact:
        • Principal Investigator:
          • Dmitry Shuster
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Recruiting
        • Hutchinson Clinic
        • Contact:
        • Principal Investigator:
          • Michael Green
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Recruiting
        • Tri-State Gastroenterology Associates
        • Principal Investigator:
          • Michael Jones
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Baton Rouge General Medical Center - Bluebonnet Campus
        • Principal Investigator:
          • Jonathon Chapman
        • Contact:
      • Lafayette, Louisiana, United States, 70503
        • Recruiting
        • Combined Gastro LLC
        • Principal Investigator:
          • Jacque Noel
        • Contact:
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • GI Alliance
        • Principal Investigator:
          • George Catinis
        • Contact:
    • Maine
      • Portland, Maine, United States, 04101
        • Recruiting
        • Portland Gastroenterology Center
        • Contact:
        • Principal Investigator:
          • Noemi Baffy
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Woodholme Gastroenterology
        • Principal Investigator:
          • Kenolisa Onwueme
        • Contact:
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • Recruiting
        • Gastro Health Research - Framingham
        • Contact:
        • Principal Investigator:
          • Steven Fine
      • New Bedford, Massachusetts, United States, 02740
        • Recruiting
        • Lucida Clinical Trials LLC
        • Principal Investigator:
          • Jason Reich
        • Contact:
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Gastroenterology Associates of Western Michigan, P.L.C.
        • Contact:
        • Principal Investigator:
          • Allan Coates
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Huron Gastro
        • Principal Investigator:
          • Najm Soofi
        • Contact:
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Withdrawn
        • MNGI Digestive Health, P.A.
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Delta Gastroenterology and Endoscopy Center
        • Contact:
        • Principal Investigator:
          • Ulric Duncan
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Active, not recruiting
        • SSM Health Medical Group
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • GI Associates Research, LLC
        • Principal Investigator:
          • Michael Williams
        • Contact:
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Mid America Gastro Intestinal Consultants
        • Principal Investigator:
          • Hillary Bownik
        • Contact:
      • Weldon Spring, Missouri, United States, 63304
        • Recruiting
        • St Charles Clinical Research
        • Principal Investigator:
          • Leonard Weinstock
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89511
        • Withdrawn
        • Advanced Research Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Withdrawn
        • Presbyterian Health care services
    • New York
      • Carmel, New York, United States, 10512
        • Recruiting
        • Westchester Putnam Gastroenterology PC
        • Contact:
        • Principal Investigator:
          • Rajiv Perinbasekar
      • Cedarhurst, New York, United States, 11516
        • Active, not recruiting
        • Five Towns Gastroenterology
      • Elmhurst, New York, United States, 11373
        • Recruiting
        • IMIDeology
        • Principal Investigator:
          • Kevin Tin
        • Contact:
      • Fresh Meadows, New York, United States, 11040
        • Active, not recruiting
        • Intercity Gastroenterology
      • Lake Success, New York, United States, 11042
        • Withdrawn
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10075
        • Withdrawn
        • Lenox Hill Hospital
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Ana Tuyama
      • New York, New York, United States, 10279
        • Withdrawn
        • Manhattan Clinical Research, LLC
      • Rochester, New York, United States, 14620
        • Withdrawn
        • Gastroenterology Group of Rochester
      • Seaford, New York, United States, 11783
        • Recruiting
        • ProHealth (Seaford) (Optum)
        • Contact:
        • Principal Investigator:
          • Corina Serer
      • Syracuse, New York, United States, 13210
        • Withdrawn
        • Syracuse VA Medical Center
      • Utica, New York, United States, 13502
        • Recruiting
        • Digestive Disease Medicine
        • Principal Investigator:
          • Harvey Allen
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Charlotte Gastroenterology and Hepatology, P.L.L.C
        • Contact:
        • Principal Investigator:
          • John Gardiner Roddey
      • Pinehurst, North Carolina, United States, 28374
        • Withdrawn
        • Pinehurst Medical Clinic Inc
      • Statesville, North Carolina, United States, 28625
      • Wilmington, North Carolina, United States, 28403
        • Recruiting
        • Wilmington Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • William King
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Gastro Health Research - Cincinnati
        • Contact:
        • Principal Investigator:
          • Matthew Atkinson
      • Dayton, Ohio, United States, 45414
        • Recruiting
        • DSI Research Northridge LLC
        • Contact:
        • Principal Investigator:
          • Cassandra Steimle
      • Liberty Township, Ohio, United States, 45044
        • Recruiting
        • Gastro Health Research - Liberty Township
        • Contact:
        • Principal Investigator:
          • Stephen Martin
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC
        • Contact:
        • Principal Investigator:
          • Keith Friedenberg
      • Springboro, Ohio, United States, 45066
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • NorthShore Gastroenterology Research, LLC
        • Principal Investigator:
          • Kimberly Harris
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • The Oregon Clinic, P.C.
        • Principal Investigator:
          • Phillip Kiyasu
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • University Gastroenterology
        • Principal Investigator:
          • Lisa Mueller
        • Contact:
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Palmetto Primary Care Physician Division of Gastroenterology
        • Principal Investigator:
          • Brett Van Leer-Greenberg
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Center for Digestive Health
        • Principal Investigator:
          • Ahmed Kurdi
        • Contact:
    • Tennessee
      • Kingsport, Tennessee, United States, 37663
        • Recruiting
        • Tri-Cities Gastroenterology
        • Principal Investigator:
          • Stephen Fry
        • Contact:
    • Texas
      • El Paso, Texas, United States, 79936
        • Recruiting
        • The Clinical Trials Network CTNX LLC
        • Contact:
        • Principal Investigator:
          • Ikenna Egbuna
      • Georgetown, Texas, United States, 78628
        • Recruiting
        • Amel Med LLC
        • Principal Investigator:
          • Masi Khaja
        • Contact:
      • Houston, Texas, United States, 77005
        • Recruiting
        • Kelsey Research Foundation
        • Contact:
        • Principal Investigator:
          • Sheela Chandra
      • Houston, Texas, United States, 77079
      • Houston, Texas, United States, 77090
        • Withdrawn
        • Integrity Advanced Therapeutics
      • Houston, Texas, United States, 77090
        • Active, not recruiting
        • Spring Clinical Research
      • Katy, Texas, United States, 77494
        • Active, not recruiting
        • Gastro health & Nutrition
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • One of a Kind Clinical Research Center LLC
        • Principal Investigator:
          • Sushovan Guha
        • Contact:
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • West Texas Research Institute
        • Contact:
        • Principal Investigator:
          • Sameer Islam
      • Tomball, Texas, United States, 77375
        • Withdrawn
        • Texas Gastro Consultants
      • Waco, Texas, United States, 76712
        • Recruiting
        • Digestive Research of Central Texas, LLC
        • Principal Investigator:
          • Hanumantha Ancha
        • Contact:
      • Webster, Texas, United States, 77598
        • Recruiting
        • GI Alliance - Webster
        • Contact:
        • Principal Investigator:
          • Syed Jafri
    • Utah
      • Ogden, Utah, United States, 84405
        • Withdrawn
        • Advanced Research Institute
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Gastroenterology Consultants of Southwest Virginia.
        • Principal Investigator:
          • Nirish Shah
        • Contact:
      • Suffolk, Virginia, United States, 23435
        • Withdrawn
        • Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
      • Williamsburg, Virginia, United States, 23188
        • Withdrawn
        • TMPG Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98405
        • Recruiting
        • GI Alliance
        • Principal Investigator:
          • Nicholas Procaccini
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. If participant is a woman of childbearing potential (WOCBP):

    1. 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.
    2. 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.
    3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
    4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.

  6. If participant is a fertile man:

    1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
    2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.

  7. 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 subscore of 2 to 3 at screening
  8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
  9. 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 (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration [FDA] 2024).
  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. 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).
  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 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.
  10. 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.
  11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.
  12. Has laboratory abnormalities during the screening period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UC Participants: Vedolizumab
Participants 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.
Drug: Vedolizumab IV
Vedolizumab IV infusion
Other Names:
  • Entyvio
Drug: Vedolizumab SC
Vedolizumab SC injection
Other Names:
  • Entyvio
Experimental: CD Participants: Vedolizumab
Participants 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.
Drug: Vedolizumab IV
Vedolizumab IV infusion
Other Names:
  • Entyvio
Drug: Vedolizumab SC
Vedolizumab SC injection
Other Names:
  • Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Time Frame: At Weeks 6 and 52
PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF <= 2.8, 7-day average of AP score <= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score <=1.
At Weeks 6 and 52
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52
Time Frame: At Weeks 6, 14, and 52
CD clinical response is defined as greater than and equal to (>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of >=3 points and >=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of >=1 point(s) or absolute rectal bleeding sub-score of <=1 point or absolute rectal bleeding sub-score of <=1 point, or a reduction in partial Mayo score of >=2 points and >=25% from baseline, if complete Mayo score was not performed at visit.
At Weeks 6, 14, and 52
Percentage of CD Participants With Endoscopic Response at Week 52
Time Frame: At Week 52
Endoscopic response is defined as >=50% reduction from baseline (or for participants with isolated ileal disease, SES-CD <= 4 or at least a 2-point reduction from baseline) in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
At Week 52
Percentage of CD Participants Achieving Endoscopic Remission at Week 52
Time Frame: At Week 52
Endoscopic remission as per SES-CD is defined as SES-CD score <=4 or <=2 for ileal disease, no subscore >1. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
At Week 52
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
Time Frame: At Week 52
Improvement of endoscopic appearance of the mucosa is defined as Mayo endoscopic sub-score = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]).
At Week 52
Percentage of UC Participants With Endoscopic Remission at Week 52
Time Frame: At Week 52
Endoscopic remission is defined as a centrally read complete Mayo endoscopy subscore of 0.
At Week 52
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52
Time Frame: At Weeks 6, 14, and 52
Clinical Remission for CD is defined as a CDAI <150 point. Clinical remission for UC is defined as complete MS of <=2 points and no participant sub-score greater than (>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment [PGA]) score of <=2 and no individual sub-score >1.
At Weeks 6, 14, and 52
Percentage of CD and UC Participants With Clinical Remission at Week 52
Time Frame: At Week 52
Clinical remission for CD is defined as a CDAI <150 point. Clinical remission for UC is defined as complete MS of <=2 points and no participant sub-score >1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of <=2 and no individual sub-score >1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.
At Week 52
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52
Time Frame: Baseline, Weeks 6, 14, and 52
Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Baseline, Weeks 6, 14, and 52
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52
Time Frame: Baseline, Weeks 6, 14, and 52
Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Baseline, Weeks 6, 14, and 52
Number of CD and UC Participants With Serious Infections
Time Frame: Up to end of study (up to 72 weeks)
Number of CD and UC participants with serious infections will be reported.
Up to end of study (up to 72 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vedolizumab-4063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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