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Um estudo de Vedolizumabe em adultos com colite ulcerativa ou doença de Crohn em ambiente comunitário (PANORAMA)

27 de outubro de 2026 atualizado por: Takeda

Um estudo de fase 4 avaliando colite ulcerativa ativa moderada a grave ou doença de Crohn e o uso de vedolizumabe subcutâneo em um ambiente comunitário

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

200

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Vedolizumab IV

Vedolizumab IV infusion

Outros nomes:
  • Entyvio
Medicamento: Vedolizumab SC

Vedolizumab SC injection

Outros nomes:
  • 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.
Medicamento: Vedolizumab IV

Vedolizumab IV infusion

Outros nomes:
  • Entyvio
Medicamento: Vedolizumab SC

Vedolizumab SC injection

Outros nomes:
  • Entyvio

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Takeda

Investigadores

  • Diretor de estudo: Study Director, Takeda

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de março de 2025

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

30 de agosto de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de agosto de 2024

Primeira postagem (Real)

3 de setembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Vedolizumab-4063

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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