Clinical trial • Phase III • Gastroenterology
Vedolizumab for Ulcerative colitis | Crohn's disease
Phase III trial of Vedolizumab for Ulcerative colitis | Crohn's disease. open-label. 38 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis | Crohn's disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 18-07-2024
- First CTIS Authorization Date
- 11-11-2024
Trial design
open-label Phase III trial across 27 sites in Italy, Romania, Ireland and others.
- Open Label
- Yes
- Target Sample Size
- 38
- Trial Duration For Participant
- 350
Eligibility
Recruits 38 paediatric patients.
- Vulnerable Population
- Pediatric participants are considered a vulnerable population. The submission includes age-specific assent tools and ICFs (assent tools for age groups 2-7, 8-11, 12-17 and parent/guardian ICFs). Materials include subject information and informed consent forms, parent/guardian forms and assent forms in multiple languages and ICF video storyboard resources. Consent is provided by the parent/legal guardian; age-appropriate assent is obtained from child participants according to the provided assent tools.
Inclusion criteria
- {"criterion_text":"- 01. The participant weighs ≥10 kg at the time of screening and enrollment into the study.\n- 02. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as: Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.) Participants with CD: a pediatric Crohn's disease activity index (PCDAI) >30 and a simple endoscopic score for Crohn's disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.\n- 03. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab).\n- 04. Participants with evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.\n- 05. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.\n- 06. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines."}
Exclusion criteria
- {"criterion_text":"- 01. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.\n- 02. Participants who have had prior exposure to vedolizumab.\n- 03. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.\n- 04. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.\n- 05. The participant has received any live vaccinations within 30 days before first dose of study drug.\n- 06. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.\n- 07. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.\n- 08. Participants with a current diagnosis of indeterminate colitis.\n- 09. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).\n- 10. Participants with active or latent tuberculosis (TB).\n- 11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (ie, HBsAg negative and hepatitis B surface antibody [anti-HBs]-positive) may, however, be included.\n- 12. The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).\n- 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.\n- 14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 01. Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 [Time Frame: Predose at Week 34]","definition_or_measurement_approach":"Steady-state median observed plasma concentration at the end of a dosing interval for vedolizumab measured predose at Week 34."}
- {"endpoint_text":"- 02. Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34 [Time Frame: Multiple time points prior to Week 34; pre-dose at Week 34]","definition_or_measurement_approach":"Average serum concentration at steady-state for vedolizumab at Week 34 measured across multiple time points prior to Week 34 and pre-dose at Week 34."}
Secondary endpoints
- {"endpoint_text":"- 01. Percentage of Participants with Positive Antivedolizumab Antibody (AVA) [Baseline up to 18 weeks after last dose of study drug (up to Week 50)]","definition_or_measurement_approach":"Proportion of participants with positive anti-vedolizumab antibodies measured from baseline through 18 weeks after the last dose (up to Week 50)."}
- {"endpoint_text":"- 02. Percentage of Participants with Positive Neutralizing AVA [Baseline up to 18 weeks after last dose of study drug (up to Week 50)]","definition_or_measurement_approach":"Proportion of participants with positive neutralizing anti-vedolizumab antibodies measured from baseline through 18 weeks after the last dose (up to Week 50)."}
Recruitment
- Registry Or Advocacy Recruitment
- True (advocacy emails/messages used; specific external advocacy organisation names are not specified in the available documents)
- Digital Remote Recruitment
- True (email communications to doctors/caregivers, advocacy emails, doctor-to-doctor emails, and ICF video storyboard / digital ICF resources)
- Planned Sample Size
- 38
- Recruitment Window Months
- 32
- Consent Approach
- Informed consent is obtained from the parent/legal guardian (parent/guardian ICF provided). Age-appropriate assent is obtained from pediatric participants using dedicated assent tools for age groups (2-7, 8-11, 12-17). Subject information and ICF documents, assent forms, parent/guardian forms and translated versions (examples: English, Romanian, Bulgarian, French, Dutch, Italian, Polish, Portuguese) are provided. Video storyboard resources are available to support informed consent.
Methods
- Doctor-to-caregiver letters and emails (K2_Doctor to Caregiver Letter / Email) directed at pediatric gastroenterologists and caregivers.
- Doctor-to-doctor letters and emails to inform/engage referring physicians (K2_Doctor to Doctor Letter / Email).
- Advocacy messages and advocacy emails targeting patient advocacy channels (K2_Advocacy Messages / K2_Advocacy Email).
- Recruitment brochures, participant study guides and subject cards distributed at sites and to caregivers (K2_Recruitment Brochure, K2_Participant Study Guide, K2_Subject Card).
- Appointment reminder cards and thank you cards for participants (K2_Appointment Reminder Card, K2_Thank You Card).
- Site-level materials and site kits (L2_Site Kit Box, L2_Site Welcome Letter) and colleague presentations to support site recruitment.
- ICF video storyboard and informational video resources to support remote/visual consent engagement (K2_ICF Video Storyboard).
- Token gifts / reimbursement information provided to participants (K2_Token Gifts) to support recruitment/retention.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 30
Italy
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 546
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Azienda Sanitaria Locale Di Pescara
- Department Name
- U.O.C. Pediatria Medica
- Principal Investigator Name
- Maria Teresa Illiceto
- Principal Investigator Email
- mariateresa.illiceto@asl.pe.it
- Contact Person Name
- Maria Teresa Illiceto
- Contact Person Email
- mariateresa.illiceto@asl.pe.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- U.O. di Pediatria e Pronto Soccorso Pediatrico
- Principal Investigator Name
- Gian Vincenzo Zuccotti
- Principal Investigator Email
- gianvincenzo.zuccotti@unimi.it
- Contact Person Name
- Gian Vincenzo Zuccotti
- Contact Person Email
- gianvincenzo.zuccotti@unimi.it
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- U.O. Gastroenterologia e Nutrizione
- Principal Investigator Name
- Paola De Angelis
- Principal Investigator Email
- paola.deangelis@opbg.net
- Contact Person Name
- Paola De Angelis
- Contact Person Email
- paola.deangelis@opbg.net
- Site Name
- Azienda Ospedaliera Universitaria Gaetano Martino Messina
- Department Name
- U.O.S.D. Gastroenterologia Pediatrica e Fibrosi Cistica
- Principal Investigator Name
- Claudio Romano
- Principal Investigator Email
- romanoc@unime.it
- Contact Person Name
- Claudio Romano
- Contact Person Email
- romanoc@unime.it
Romania
- Earliest CTIS Part Ii Submission Date
- 15-10-2024
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 484
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- Pediatrie II
- Principal Investigator Name
- Corina Pienar
- Principal Investigator Email
- pediatrie@hosptm.ro
- Contact Person Name
- Corina Pienar
- Contact Person Email
- pediatrie@hosptm.ro
- Site Name
- Dr. Victor Gomoiu Clinical Children Hospital
- Department Name
- Pediatrie 2
- Principal Investigator Name
- Iulia Florentina Tincu
- Principal Investigator Email
- secretariat@spitalgomoiu.ro
- Contact Person Name
- Iulia Florentina Tincu
- Contact Person Email
- secretariat@spitalgomoiu.ro
- Site Name
- Spitalul Clinic De Urgenta Pentru Copii Grigore Alexandrescu
- Department Name
- Pediatrie 2
- Principal Investigator Name
- Cristina Adriana Becheanu
- Principal Investigator Email
- laboratorgrigore@yahoo.com
- Contact Person Name
- Cristina Adriana Becheanu
- Contact Person Email
- laboratorgrigore@yahoo.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 538
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Children's Health Ireland
- Department Name
- Gastroenterology
- Principal Investigator Name
- Seamus Hussey
- Principal Investigator Email
- seamus.hussey@ucd.ie
- Contact Person Name
- Seamus Hussey
- Contact Person Email
- seamus.hussey@ucd.ie
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 498
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
- Department Name
- Clinic of Children’s Gastroenterology
- Principal Investigator Name
- Mila Baycheva
- Principal Investigator Email
- mila.baycheva@gmail.com
- Contact Person Name
- Mila Baycheva
- Contact Person Email
- mila.baycheva@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of pediatrics
- Principal Investigator Name
- Ivan Yankov
- Principal Investigator Email
- epediatrics@abv.bg
- Contact Person Name
- Ivan Yankov
- Contact Person Email
- epediatrics@abv.bg
Portugal
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 508
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Maria Helena Loreto
- Principal Investigator Email
- helena.loreto@ulssm.min-saude.pt
- Contact Person Name
- Maria Helena Loreto
- Contact Person Email
- helena.loreto@ulssm.min-saude.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Rosa Lima
- Principal Investigator Email
- ensaiosclinicos.defi@chporto.min-saude.pt
- Contact Person Name
- Rosa Lima
- Contact Person Email
- ensaiosclinicos.defi@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Carla Maia
- Principal Investigator Email
- inesmatos.silva@blueclinical.pt
- Contact Person Name
- Carla Maia
- Contact Person Email
- inesmatos.silva@blueclinical.pt
Poland
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 516
- Number Of Sites
- 6
- Number Of Participants
- 9
Sites
- Site Name
- Uniwersytecki Szpital Dzieciecy W Krakowie
- Department Name
- Klinika Pediatrii, Gastroenterologii i Żywienia
- Principal Investigator Name
- Kinga Kowalska-Duplaga
- Principal Investigator Email
- pedgi@mp.pl
- Contact Person Name
- Kinga Kowalska-Duplaga
- Contact Person Email
- pedgi@mp.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Gastroenterologii i Hepatologii Dzieci
- Principal Investigator Name
- Jarosław Kwiecień
- Principal Investigator Email
- gastro-p@szpital.zabrze.pl
- Contact Person Name
- Jarosław Kwiecień
- Contact Person Email
- gastro-p@szpital.zabrze.pl
- Site Name
- Korczowski Bartosz, Gabinet Lekarski
- Principal Investigator Name
- Bartosz Korczowski
- Principal Investigator Email
- korczowski@op.pl
- Contact Person Name
- Bartosz Korczowski
- Contact Person Email
- korczowski@op.pl
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- WIP Warsaw IBD Point Profesor Kierkuś
- Principal Investigator Name
- Monika Meglicka
- Principal Investigator Email
- j.kierkus@wip.waw.pl
- Contact Person Name
- Monika Meglicka
- Contact Person Email
- j.kierkus@wip.waw.pl
- Site Name
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
- Department Name
- Centrum Nowoczesnych Terapii "Dobry Lekarz" Spółka z ograniczoną odpowiedzialnością
- Principal Investigator Name
- Małgorzata Sładek
- Principal Investigator Email
- katarzyna.gajda@dobrylekarz.com.pl
- Contact Person Name
- Małgorzata Sładek
- Contact Person Email
- katarzyna.gajda@dobrylekarz.com.pl
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii
- Principal Investigator Name
- Jarosław Kierkuś
- Principal Investigator Email
- ibd@ipczd.pl
- Contact Person Name
- Jarosław Kierkuś
- Contact Person Email
- ibd@ipczd.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 15-10-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 518
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Gastroenterology and Hepatology Unit
- Principal Investigator Name
- Ester Donat Aliaga
- Principal Investigator Email
- est@gva.es
- Contact Person Name
- Ester Donat Aliaga
- Contact Person Email
- est@gva.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Digestive service
- Principal Investigator Name
- Federico Argüelles Arias
- Principal Investigator Email
- arguelles@telefonica.net
- Contact Person Name
- Federico Argüelles Arias
- Contact Person Email
- arguelles@telefonica.net
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- Digestive service
- Principal Investigator Name
- Ana Isabel Echarri Piudo
- Principal Investigator Email
- Ana.Echarri.Piudo@sergas.es
- Contact Person Name
- Ana Isabel Echarri Piudo
- Contact Person Email
- Ana.Echarri.Piudo@sergas.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Section of Pediatric Gastroenterology and Hepatology Department of Pediatrics
- Principal Investigator Name
- Enrique Medina Benitez
- Principal Investigator Email
- Enrique.medina@salud.madrid.org
- Contact Person Name
- Enrique Medina Benitez
- Contact Person Email
- Enrique.medina@salud.madrid.org
Denmark
- Earliest CTIS Part Ii Submission Date
- 01-11-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 503
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Hvidovre Hospital
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Lars Folmer Hansen
- Principal Investigator Email
- Lars.folmer.hansen@regionh.dk
- Contact Person Name
- Lars Folmer Hansen
- Contact Person Email
- Lars.folmer.hansen@regionh.dk
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 533
- Number Of Sites
- 1
- Number Of Participants
- 0
Sites
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- MDL
- Principal Investigator Name
- Gerard Damen
- Principal Investigator Email
- Gerard.Damen@radboudumc.nl
- Contact Person Name
- Gerard Damen
- Contact Person Email
- Gerard.Damen@radboudumc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 578
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pediatric Gastroenterology and Hepatology
- Principal Investigator Name
- Isabelle Scheers
- Principal Investigator Email
- isabelle.scheers@saintluc.uclouvain.be
- Contact Person Name
- Isabelle Scheers
- Contact Person Email
- isabelle.scheers@saintluc.uclouvain.be
- Site Name
- CHC MontLegia
- Department Name
- Gastropediatric department
- Principal Investigator Name
- Stephanie Colinet
- Principal Investigator Email
- Stephanie.colinet@chc.be
- Contact Person Name
- Stephanie Colinet
- Contact Person Email
- Stephanie.colinet@chc.be
Sponsor
Primary sponsor
- Full Name
- Takeda Development Center Americas Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Codes 1,12,13,5 (multiple central trial management responsibilities listed in sponsorDuties)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code 4
- Name
- QPS LLC
- Responsibilities
- sponsorDuties code 4
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging (sponsorDuties code 15)
- Name
- Signant Health Global LLC
- Responsibilities
- sponsorDuties code 7 (electronic patient-reported outcomes/eCOA vendor responsibilities likely)
- Name
- Endpoint Clinical Inc.
- Responsibilities
- sponsorDuties code 3
- Name
- Almac Clinical Services LLC
- Responsibilities
- sponsorDuties code 14
- Name
- Azenta US Inc.
- Responsibilities
- Long term sample storage (sponsorDuties code 15)
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging (sponsorDuties code 15; value: Imaging)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient recruitement and Advertisement Material (sponsorDuties codes 10 and 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement (sponsorDuties code 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage (sponsorDuties code 15, value: Long term sample storage)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes 1,12,13,5","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Entyvio 108 mg solution for injection in pre-filled syringe
- Active Substance
- Vedolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/14/923/002)
- Maximum Dose
- 108 mg
- Investigational Product Name
- Entyvio 300 mg powder for concentrate for solution for infusion
- Active Substance
- Vedolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/14/923/001)
- Maximum Dose
- 300 mg
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