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En undersøgelse af vedolizumab hos voksne med colitis ulcerosa eller Crohns sygdom i lokalsamfundet (PANORAMA)

27. oktober 2026 opdateret af: Takeda

Et fase 4-studie, der evaluerer moderat til svært aktiv colitis ulcerosa eller Crohns sygdom og brugen af ​​vedolizumab subkutant i et lokalsamfund

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35243
        • Rekruttering
        • Gastro Health
        • Kontakt:
        • Ledende efterforsker:
          • Robert Shaffer
      • Mobile, Alabama, Forenede Stater, 36608
        • Rekruttering
        • East View Medical Research
        • Ledende efterforsker:
          • Jonathan Siegel
        • Kontakt:
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Rekruttering
        • AZ Gastro Care
        • Kontakt:
        • Ledende efterforsker:
          • Shahbaz Ali Qureshi
      • Gilbert, Arizona, Forenede Stater, 85297
        • Rekruttering
        • Spectrum Research Institute LLC
        • Ledende efterforsker:
          • Donna DeSantis
        • Kontakt:
      • Sun City, Arizona, Forenede Stater, 85351
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Trukket tilbage
        • UAMS Health Gastroenterology Clinic
    • California
      • Escondido, California, Forenede Stater, 92025
        • Rekruttering
        • Gastroenterology and Liver Institute
        • Ledende efterforsker:
          • Naveen Gara
        • Kontakt:
      • Murrieta, California, Forenede Stater, 92562
        • Trukket tilbage
        • Inland Empire Gastroenterology
      • Murrieta, California, Forenede Stater, 92563
        • Rekruttering
        • United Clinical Research Institute
        • Ledende efterforsker:
          • John Hong
        • Kontakt:
      • Newport Beach, California, Forenede Stater, 92663
        • Trukket tilbage
        • Digestive Health Institute
      • Orange, California, Forenede Stater, 92868
        • Trukket tilbage
        • Knowledge Research Center
      • San Diego, California, Forenede Stater, 92123
        • Trukket tilbage
        • Medical Associates Research Group, Inc.
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rekruttering
        • Peak Gastroenterology Associates
        • Ledende efterforsker:
          • Bhaktasharan Patel
        • Kontakt:
      • Littleton, Colorado, Forenede Stater, 80120
        • Rekruttering
        • Rocky Mountain Endocopy Centers LLC
        • Ledende efterforsker:
          • Erik Springer
        • Kontakt:
    • Florida
      • Brooksville, Florida, Forenede Stater, 34613
        • Rekruttering
        • Access Research Institute
        • Kontakt:
        • Ledende efterforsker:
          • Salman Muddassir
      • Clearwater, Florida, Forenede Stater, 33762
        • Rekruttering
        • Gastro Florida
        • Kontakt:
        • Ledende efterforsker:
          • Michael Weiss
      • Hialeah, Florida, Forenede Stater, 33016
        • Trukket tilbage
        • Doral Medical Research, LLC
      • Kissimmee, Florida, Forenede Stater, 34741
        • Rekruttering
        • Digestive and Liver Center of Florida, P.A.
        • Ledende efterforsker:
          • Basher Atiquzzaman
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33176
        • Rekruttering
        • Gastro Health Research - Miami
        • Kontakt:
        • Ledende efterforsker:
          • Joanna Lopez
      • Orlando, Florida, Forenede Stater, 32803
        • Rekruttering
        • Endoscopic Research, Inc.
        • Kontakt:
        • Ledende efterforsker:
          • Marlon Ilagan
      • Orlando, Florida, Forenede Stater, 32825
        • Trukket tilbage
        • Digestive and Liver Center of Florida
      • Orlando, Florida, Forenede Stater, 32806
        • Rekruttering
        • Orlando Health-Orlando Regional Medical Center
        • Ledende efterforsker:
          • Udayakumar Navaneethan
        • Kontakt:
      • Pensacola, Florida, Forenede Stater, 32504
        • Rekruttering
        • Gastro Health Research - Pensacola
        • Ledende efterforsker:
          • Frederic Newman
        • Kontakt:
      • Pinellas Park, Florida, Forenede Stater, 33781
        • Rekruttering
        • West Central Gastroenterology d/b/a Gastro Florida
        • Ledende efterforsker:
          • Tejinder Glamour
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30327
        • Rekruttering
        • Digestive Healthcare of Georgia
        • Kontakt:
        • Ledende efterforsker:
          • Michael Galambos
      • Atlanta, Georgia, Forenede Stater, 30342
        • Rekruttering
        • AGA GA Research LLC
        • Ledende efterforsker:
          • Justin Mendel
        • Kontakt:
      • Decatur, Georgia, Forenede Stater, 30033
        • Trukket tilbage
        • Atlanta Center for Gastroenterology, P.C.
    • Illinois
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Rekruttering
        • Yapp, Rockford M.D. (Private Practice)
        • Ledende efterforsker:
          • Rockford Yapp
        • Kontakt:
      • Glenview, Illinois, Forenede Stater, 60026
        • Rekruttering
        • GI Alliance - Glenview
        • Kontakt:
        • Ledende efterforsker:
          • Nina Merel
      • Lake Barrington, Illinois, Forenede Stater, 60010
        • Rekruttering
        • Gastroenterology and Internal Medicine Specialists, SC
        • Ledende efterforsker:
          • Manish Bhuva
        • Kontakt:
      • Naperville, Illinois, Forenede Stater, 60540
        • Trukket tilbage
        • Suburban Gastroenterology
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Rekruttering
        • GI Partners of Illinois - Southwest Gastroenterology
        • Ledende efterforsker:
          • Charles Berkelhammer
        • Kontakt:
      • Rockford, Illinois, Forenede Stater, 61107
        • Rekruttering
        • Rockford Gastroenterology Associates, Ltd.
        • Ledende efterforsker:
          • Sunil Patel
        • Kontakt:
      • Springfield, Illinois, Forenede Stater, 62703
        • Rekruttering
        • Springfield Clinic
        • Kontakt:
        • Ledende efterforsker:
          • Dmitry Shuster
    • Indiana
      • Westfield, Indiana, Forenede Stater, 46074
        • Rekruttering
        • Riverview Health
        • Ledende efterforsker:
          • Sashidhar Sagi
        • Kontakt:
    • Kansas
      • Hutchinson, Kansas, Forenede Stater, 67502
        • Rekruttering
        • Hutchinson Clinic
        • Kontakt:
        • Ledende efterforsker:
          • Michael Green
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017
        • Rekruttering
        • Tri-State Gastroenterology Associates
        • Ledende efterforsker:
          • Michael Jones
        • Kontakt:
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Rekruttering
        • Baton Rouge General Medical Center - Bluebonnet Campus
        • Ledende efterforsker:
          • Jonathon Chapman
        • Kontakt:
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Rekruttering
        • Combined Gastro LLC
        • Ledende efterforsker:
          • Jacque Noel
        • Kontakt:
      • Metairie, Louisiana, Forenede Stater, 70006
        • Rekruttering
        • GI Alliance
        • Ledende efterforsker:
          • George Catinis
        • Kontakt:
    • Maine
      • Portland, Maine, Forenede Stater, 04101
        • Rekruttering
        • Portland Gastroenterology Center
        • Kontakt:
        • Ledende efterforsker:
          • Noemi Baffy
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
      • Glen Burnie, Maryland, Forenede Stater, 21061
        • Rekruttering
        • Woodholme Gastroenterology
        • Ledende efterforsker:
          • Kenolisa Onwueme
        • Kontakt:
    • Massachusetts
      • Framingham, Massachusetts, Forenede Stater, 01702
        • Rekruttering
        • Gastro Health Research - Framingham
        • Kontakt:
        • Ledende efterforsker:
          • Steven Fine
      • New Bedford, Massachusetts, Forenede Stater, 02740
        • Rekruttering
        • Lucida Clinical Trials LLC
        • Ledende efterforsker:
          • Jason Reich
        • Kontakt:
    • Michigan
      • Wyoming, Michigan, Forenede Stater, 49519
        • Rekruttering
        • Gastroenterology Associates of Western Michigan, P.L.C.
        • Kontakt:
        • Ledende efterforsker:
          • Allan Coates
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Rekruttering
        • Huron Gastro
        • Ledende efterforsker:
          • Najm Soofi
        • Kontakt:
    • Minnesota
      • Plymouth, Minnesota, Forenede Stater, 55446
        • Trukket tilbage
        • MNGI Digestive Health, P.A.
    • Mississippi
      • Southaven, Mississippi, Forenede Stater, 38671
        • Rekruttering
        • Delta Gastroenterology and Endoscopy Center
        • Kontakt:
        • Ledende efterforsker:
          • Ulric Duncan
    • Missouri
      • Bridgeton, Missouri, Forenede Stater, 63044
        • Rekruttering
        • SSM Health Medical Group
        • Ledende efterforsker:
          • Yezaz Ghouri
        • Kontakt:
      • Columbia, Missouri, Forenede Stater, 65201
        • Rekruttering
        • GI Associates Research, LLC
        • Ledende efterforsker:
          • Michael Williams
        • Kontakt:
      • Kansas City, Missouri, Forenede Stater, 64111
        • Rekruttering
        • Mid America Gastro Intestinal Consultants
        • Ledende efterforsker:
          • Hillary Bownik
        • Kontakt:
      • Weldon Spring, Missouri, Forenede Stater, 63304
        • Rekruttering
        • St Charles Clinical Research
        • Ledende efterforsker:
          • Leonard Weinstock
        • Kontakt:
    • Nevada
      • Reno, Nevada, Forenede Stater, 89511
        • Trukket tilbage
        • Advanced Research Institute
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87107
        • Trukket tilbage
        • Presbyterian Health care services
    • New York
      • Carmel, New York, Forenede Stater, 10512
        • Rekruttering
        • Westchester Putnam Gastroenterology PC
        • Kontakt:
        • Ledende efterforsker:
          • Rajiv Perinbasekar
      • Cedarhurst, New York, Forenede Stater, 11516
        • Rekruttering
        • Five Towns Gastroenterology
        • Kontakt:
        • Ledende efterforsker:
          • Marc Fenster
      • Elmhurst, New York, Forenede Stater, 11373
        • Rekruttering
        • IMIDeology
        • Ledende efterforsker:
          • Kevin Tin
        • Kontakt:
      • Fresh Meadows, New York, Forenede Stater, 11040
        • Rekruttering
        • Intercity Gastroenterology
        • Ledende efterforsker:
          • Ghulamullah Shahzad
        • Kontakt:
      • Lake Success, New York, Forenede Stater, 11042
        • Trukket tilbage
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, Forenede Stater, 10075
        • Trukket tilbage
        • Lenox Hill Hospital
      • New York, New York, Forenede Stater, 10075
        • Rekruttering
        • New York Gastroenterology Associates
        • Kontakt:
        • Ledende efterforsker:
          • Ana Tuyama
      • New York, New York, Forenede Stater, 10279
        • Trukket tilbage
        • Manhattan Clinical Research, LLC
      • Rochester, New York, Forenede Stater, 14620
        • Trukket tilbage
        • Gastroenterology Group of Rochester
      • Seaford, New York, Forenede Stater, 11783
        • Rekruttering
        • ProHealth (Seaford) (Optum)
        • Kontakt:
        • Ledende efterforsker:
          • Corina Serer
      • Syracuse, New York, Forenede Stater, 13210
        • Trukket tilbage
        • Syracuse VA Medical Center
      • Utica, New York, Forenede Stater, 13502
        • Rekruttering
        • Digestive Disease Medicine
        • Ledende efterforsker:
          • Harvey Allen
        • Kontakt:
      • West Nyack, New York, Forenede Stater, 10994
        • Rekruttering
        • Crystal Run (Optum)
        • Kontakt:
        • Ledende efterforsker:
          • Tehseen Haider
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Rekruttering
        • Charlotte Gastroenterology and Hepatology, P.L.L.C
        • Kontakt:
        • Ledende efterforsker:
          • John Gardiner Roddey
      • Greenville, North Carolina, Forenede Stater, 27834
        • Rekruttering
        • Carolina Digestive Diseases
        • Ledende efterforsker:
          • Phillip Goldstein
        • Kontakt:
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Trukket tilbage
        • Pinehurst Medical Clinic Inc
      • Statesville, North Carolina, Forenede Stater, 28625
      • Wilmington, North Carolina, Forenede Stater, 28403
        • Rekruttering
        • Wilmington Gastroenterology Associates
        • Kontakt:
        • Ledende efterforsker:
          • William King
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Rekruttering
        • Gastro Health Research - Cincinnati
        • Kontakt:
        • Ledende efterforsker:
          • Matthew Atkinson
      • Dayton, Ohio, Forenede Stater, 45414
        • Rekruttering
        • DSI Research Northridge LLC
        • Kontakt:
        • Ledende efterforsker:
          • Rajeev Kurapati
      • Liberty Township, Ohio, Forenede Stater, 45044
        • Rekruttering
        • Gastro Health Research - Liberty Township
        • Kontakt:
        • Ledende efterforsker:
          • Stephen Martin
      • Mentor, Ohio, Forenede Stater, 44060
        • Rekruttering
        • Great Lakes Gastroenterology Research, LLC
        • Kontakt:
        • Ledende efterforsker:
          • Keith Friedenberg
      • Springboro, Ohio, Forenede Stater, 45066
        • Rekruttering
        • DSI Research LLC
        • Ledende efterforsker:
          • Anjali Morey
        • Kontakt:
      • Westlake, Ohio, Forenede Stater, 44145
        • Rekruttering
        • NorthShore Gastroenterology Research, LLC
        • Ledende efterforsker:
          • Kimberly Harris
        • Kontakt:
    • Oregon
      • Portland, Oregon, Forenede Stater, 97220
        • Rekruttering
        • The Oregon Clinic, P.C.
        • Ledende efterforsker:
          • Phillip Kiyasu
        • Kontakt:
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02904
        • Rekruttering
        • University Gastroenterology
        • Ledende efterforsker:
          • Lisa Mueller
        • Kontakt:
    • South Carolina
      • Summerville, South Carolina, Forenede Stater, 29486
        • Rekruttering
        • Palmetto Primary Care Physician Division of Gastroenterology
        • Ledende efterforsker:
          • Brett Van Leer-Greenberg
        • Kontakt:
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Rekruttering
        • Sanford Center for Digestive Health
        • Ledende efterforsker:
          • Ahmed Kurdi
        • Kontakt:
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37663
        • Rekruttering
        • Tri-Cities Gastroenterology
        • Ledende efterforsker:
          • Stephen Fry
        • Kontakt:
    • Texas
      • El Paso, Texas, Forenede Stater, 79936
        • Rekruttering
        • The Clinical Trials Network CTNX LLC
        • Kontakt:
        • Ledende efterforsker:
          • Ikenna Egbuna
      • Georgetown, Texas, Forenede Stater, 78628
        • Rekruttering
        • Amel Med LLC
        • Ledende efterforsker:
          • Masi Khaja
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77005
        • Rekruttering
        • Kelsey Research Foundation
        • Kontakt:
        • Ledende efterforsker:
          • Sheela Chandra
      • Houston, Texas, Forenede Stater, 77090
        • Rekruttering
        • Spring Clinical Research
        • Ledende efterforsker:
          • Sushma Gorrela
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77079
      • Houston, Texas, Forenede Stater, 77090
        • Trukket tilbage
        • Integrity Advanced Therapeutics
      • Katy, Texas, Forenede Stater, 77494
        • Rekruttering
        • Gastro Health & Nutrition
        • Ledende efterforsker:
          • Dharmendra Verma
        • Kontakt:
      • Kingwood, Texas, Forenede Stater, 77339
        • Rekruttering
        • One of a Kind Clinical Research Center LLC
        • Ledende efterforsker:
          • Sushovan Guha
        • Kontakt:
      • Lubbock, Texas, Forenede Stater, 79424
        • Rekruttering
        • West Texas Research Institute
        • Kontakt:
        • Ledende efterforsker:
          • Sameer Islam
      • Tomball, Texas, Forenede Stater, 77375
        • Trukket tilbage
        • Texas Gastro Consultants
      • Waco, Texas, Forenede Stater, 76712
        • Rekruttering
        • Digestive Research of Central Texas, LLC
        • Ledende efterforsker:
          • Hanumantha Ancha
        • Kontakt:
      • Webster, Texas, Forenede Stater, 77598
        • Rekruttering
        • GI Alliance - Webster
        • Kontakt:
        • Ledende efterforsker:
          • Syed Jafri
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Trukket tilbage
        • Advanced Research Institute
    • Virginia
      • Roanoke, Virginia, Forenede Stater, 24014
        • Rekruttering
        • Gastroenterology Consultants of Southwest Virginia.
        • Ledende efterforsker:
          • Nirish Shah
        • Kontakt:
      • Suffolk, Virginia, Forenede Stater, 23435
        • Trukket tilbage
        • Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
      • Williamsburg, Virginia, Forenede Stater, 23188
        • Trukket tilbage
        • TMPG Clinical Research
    • Washington
      • Bellevue, Washington, Forenede Stater, 98405
        • Rekruttering
        • GI Alliance
        • Ledende efterforsker:
          • Nicholas Procaccini
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Vedolizumab IV

Vedolizumab IV infusion

Andre navne:
  • Entyvio
Medicin: Vedolizumab SC

Vedolizumab SC injection

Andre navne:
  • Entyvio
Eksperimentel: 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.
Medicin: Vedolizumab IV

Vedolizumab IV infusion

Andre navne:
  • Entyvio
Medicin: Vedolizumab SC

Vedolizumab SC injection

Andre navne:
  • Entyvio

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Tidsramme: 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
Tidsramme: 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 or absolute rectal bleeding sub-score of <=1 point or an 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
Tidsramme: At Week 52

Endoscopic response is defined as a >=50% 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
Tidsramme: At Week 52

Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 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
Tidsramme: At Week 52

Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1.
At Week 52
Percentage of UC Participants With Endoscopic Remission at Week 52
Tidsramme: At Week 52

Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0.
At Week 52
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52
Tidsramme: 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
Tidsramme: 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, 26, and 52
Tidsramme: Baseline, Weeks 6, 14, 26, and 52

Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported.
Baseline, Weeks 6, 14, 26, and 52
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52
Tidsramme: 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
Percentage of CD and UC Participants With Serious Infections
Tidsramme: Up to end of study (up to 72 weeks)

Percentage of CD and UC participants with serious infections will be reported.
Up to end of study (up to 72 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Efterforskere

  • Studieleder: Study Director, Takeda

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. marts 2025

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

30. august 2024

Først indsendt, der opfyldte QC-kriterier

30. august 2024

Først opslået (Faktiske)

3. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Vedolizumab-4063

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner