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Een onderzoek naar vedolizumab bij volwassenen met colitis ulcerosa of de ziekte van Crohn in de gemeenschapssetting (PANORAMA)

27 oktober 2026 bijgewerkt door: Takeda

Een fase 4-onderzoek ter evaluatie van matige tot ernstig actieve colitis ulcerosa of de ziekte van Crohn en het subcutane gebruik van vedolizumab binnen een gemeenschapssetting

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Vedolizumab IV

Vedolizumab IV infusion

Andere namen:
  • Entyvio
Geneesmiddel: Vedolizumab SC

Vedolizumab SC injection

Andere namen:
  • Entyvio
Experimenteel: 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.
Geneesmiddel: Vedolizumab IV

Vedolizumab IV infusion

Andere namen:
  • Entyvio
Geneesmiddel: Vedolizumab SC

Vedolizumab SC injection

Andere namen:
  • Entyvio

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Onderzoekers

  • Studie directeur: Study Director, Takeda

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 maart 2025

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

30 augustus 2024

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2024

Eerst geplaatst (Werkelijk)

3 september 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

27 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Vedolizumab-4063

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren