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Uno studio su Vedolizumab negli adulti con colite ulcerosa o malattia di Crohn in ambito comunitario (PANORAMA)

27 ottobre 2026 aggiornato da: Takeda

Uno studio di fase 4 che valuta la colite ulcerosa o la malattia di Crohn da moderata a grave e l'uso di Vedolizumab per via sottocutanea in un contesto comunitario

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Vedolizumab IV

Vedolizumab IV infusion

Altri nomi:
  • Entyvio
Droga: Vedolizumab SC

Vedolizumab SC injection

Altri nomi:
  • Entyvio
Sperimentale: 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.
Droga: Vedolizumab IV

Vedolizumab IV infusion

Altri nomi:
  • Entyvio
Droga: Vedolizumab SC

Vedolizumab SC injection

Altri nomi:
  • Entyvio

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Takeda

Investigatori

  • Direttore dello studio: Study Director, Takeda

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 marzo 2025

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

30 agosto 2024

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2024

Primo Inserito (Effettivo)

3 settembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Vedolizumab-4063

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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