Clinical trial • Phase III • Gastroenterology
Vedolizumab for Ulcerative colitis | Crohn's disease
Phase III trial of Vedolizumab for Ulcerative colitis | Crohn's disease.
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
- 05-06-2025
- First CTIS Authorization Date
- 29-09-2025
Trial design
Randomised, open-label, vedolizumab sc administered via prefilled syringe as part of an autoinjector pen (pfs+ai) versus vedolizumab sc administered via prefilled syringe with a needle safety device (pfs+nsd). dose and schedule not specified in the ctis record.-controlled Phase III trial in Belgium, Bulgaria, Denmark and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Vedolizumab SC administered via prefilled syringe as part of an autoinjector pen (PFS+AI) versus vedolizumab SC administered via prefilled syringe with a needle safety device (PFS+NSD). Dose and schedule not specified in the CTIS record.
- Real World Control
- Yes
- Target Sample Size
- 34
- Trial Duration For Participant
- 730
Eligibility
Recruits 34 paediatric patients.
- Pregnancy Exclusion
- 01. The subject is female and is lactating or pregnant
- Vulnerable Population
- Pediatric subjects (<18 years) are included. Consent must be signed and dated by the subject, subject’s legally authorized representative, parent, or legal guardian (adult caregiver) and/or pediatric assent forms must be completed as required by local regulations; age‑specific assent and parent/guardian ICFs are provided (multiple assent forms for age ranges and parent/legal guardian ICFs).
Inclusion criteria
- {"criterion_text":"- 01. In the opinion of the investigator, the subject or subject’s legally authorized representative, subject’s parent, or legal guardian (adult caregiver) is capable of understanding and complying with protocol requirements"}
- {"criterion_text":"- 02. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written treatment cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations"}
- {"criterion_text":"- 03. The subject is male or female with UC or CD and aged <18 years. (Note: subjects who reach adult age [18 years in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation)"}
- {"criterion_text":"- 04. The subject completed Week 34 of Study VedolizumabSC-3003 and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for subjects with UC is defined as a reduction of partial Mayo score of ≥2 points and ≥25% from baseline (from VedolizumabSC-3003), including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Clinical response for subjects with CD is defined as a PCDAI ≤30 with a reduction in the PCDAI of ≥15 points from baseline (from VedolizumabSC-3003)"}
- {"criterion_text":"- 05. A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (eg, condom with spermicide) from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception"}
- {"criterion_text":"- 06. A female subject of childbearing potential who is sexually active with a non-sterilized male partner agrees to use a highly effective method of contraception from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose"}
- {"criterion_text":"- Observational Cohort: 01. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written observational cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations."}
- {"criterion_text":"- Observational Cohort: 02. The subject has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 but was not eligible to enroll in the treatment cohort of this study"}
Exclusion criteria
- {"criterion_text":"- 01. The subject is female and is lactating or pregnant"}
- {"criterion_text":"- 02. The subject has hypersensitivity or allergies to vedolizumab or any of its excipients"}
- {"criterion_text":"- 03. The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study"}
- {"criterion_text":"- 04. The subject developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety."}
- {"criterion_text":"- 05. The subject has other serious comorbidities that will limit their ability to complete the study"}
- {"criterion_text":"- 06. The subject is unable to comply with all study assessments"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development).","definition_or_measurement_approach":"Incidence (occurrence) of the listed safety events recorded during the observational cohort follow-up (events captured as SAEs/serious infections/malignancies/PML/bowel surgery and growth/puberty delay as specified)."}
- {"endpoint_text":"- Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions)","definition_or_measurement_approach":"Incidence of AEs, SAEs and AESIs during treatment follow-up; AESIs defined to include infections (including opportunistic infections such as PML), liver injury, malignancies, injection-site or systemic reactions (including anaphylaxis and hypersensitivity). Events captured and reported per standard safety reporting during study visits."}
Secondary endpoints
- {"endpoint_text":"- Treatment Cohort: Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures) from Day 1 of Study VedolizumabSC-3004.","definition_or_measurement_approach":"Time-to-event measure measured from Day 1 to occurrence of first major IBD-related event (hospitalization, surgery, or procedure)."}
- {"endpoint_text":"- Changes from baseline of Study VedolizumabSC-3003 in IMPACT-III total and subscale scores for subjects aged 9 to 17 years","definition_or_measurement_approach":"Change-from-baseline in IMPACT-III questionnaire total and subscale scores for subjects aged 9–17 years (baseline defined as values from VedolizumabSC-3003)."}
Recruitment
- Planned Sample Size
- 34
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent must be signed and dated by the subject, subject’s legally authorized representative, parent, or legal guardian (adult caregiver) prior to any study procedures; pediatric assent forms are required as applicable. Multiple age‑specific assent and parent/legal guardian informed consent forms are provided (assent forms for age bands such as under 6, 6–11, 8–11, 12–14, 12–16/12–17, 15–17, etc.). Documents are available in multiple languages (examples in the submission: English, Bulgarian, Spanish, Portuguese, Polish, Dutch, Romanian, French) as per country-specific documents listed.
Methods
- GP letters to primary care/providers (documents named K2_GP Letter exist for multiple countries) - channel: letter/email to clinicians; target audience: general practitioners/pediatricians to refer eligible pediatric patients.
- Patient recruitment and advertisement materials via Clinical Trial Media Inc. - channel: advertising/recruitment materials; target audience: patients and parents/caregivers; duties noted as 'Patient recruitement and Advertisement Material'.
- Site-based recruitment and patient reimbursement managed by Scout Clinical (patient reimbursement) - channel: site-level outreach and reimbursement; target audience: participants/parents.
- Site-specific patient recruitment procedures and informed consent process documents (K1_Recruit and IC Proced) provided per country (country-specific recruitment/ICF procedures present for e.g., Romania, Spain, Portugal, Poland, Netherlands, Italy, Belgium, Bulgaria, Denmark, Ireland).
- Provision of travel support/IP travel bag to participants (K2_IP Travel bag documents) - channel: logistical support via sites; target audience: participants/parents to facilitate attendance.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 32
Belgium
- Earliest CTIS Part Ii Submission Date
- 01-09-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 193
- 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
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 17
- 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
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Pediatric Department of Gastroenterology
- 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
Ireland
- Earliest CTIS Part Ii Submission Date
- 01-09-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 32
- 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
- dochas@childrenshealthireland.ie
- Contact Person Name
- Seamus Hussey
- Contact Person Email
- dochas@childrenshealthireland.ie
Romania
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 02-10-2025
- Processing Time Days
- 27
- 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
- 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
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 01-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- 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 Y Politecnico La Fe
- Department Name
- Gastroenterology and Hepatology Unit
- Principal Investigator Name
- Ester Donat Aliaga
- Principal Investigator Email
- donat_est@gva.es
- Contact Person Name
- Ester Donat Aliaga
- Contact Person Email
- donat_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
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 38
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- 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
- Site Name
- Korczowski Bartosz Gabinet Lekarski
- Department Name
- -
- 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
- 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
- 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
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- 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
Portugal
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 94
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- 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
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 22-08-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 259
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- 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
- Site Name
- Azienda Sanitaria Locale Di Pescara
- Department Name
- U.O.C. Pediatria Medica-Ospedale S. Spirito, Via Fonte Romana, 8 – 65125 Pescara (Italy)
- 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
- 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
- ASST Fatebenefratelli Sacco
- Department Name
- U.O. di Pediatria e Pronto Soccorso Pediatrico Ospedale dei Bambini “Vittore Buzzi”
- Principal Investigator Name
- Francesca Penagini
- Principal Investigator Email
- Francesca.penagini@asst-fbf-sacco.it
- Contact Person Name
- Francesca Penagini
- Contact Person Email
- Francesca.penagini@asst-fbf-sacco.it
Sponsor
Primary sponsor
- Full Name
- Takeda Development Center Americas Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- QPS LLC
- Name
- Pharmaceutical Product Development LLC
- Name
- Icon Clinical Research Limited
- Responsibilities
- codes: 1,12,13,5
- Name
- Endpoint Clinical Inc.
- Name
- Almac Clinical Services LLC
- Responsibilities
- code: 14
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,12,13,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient recruitement and Advertisement Material; codes: 10,15","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 injection
- Route
- Subcutaneous injection
- Authorisation Status
- Marketing authorisation present
- Starting Dose
- 108 mg noted as available dose (no explicit starting dose/schedule in CTIS record)
- Maximum Dose
- 5184 mg (maxTotalDoseAmount)
- Investigational Product Name
- Entyvio 108 mg solution for injection in pre-filled pen
- Active Substance
- Vedolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Marketing authorisation present
- Starting Dose
- 108 mg noted as available dose (no explicit starting dose/schedule in CTIS record)
- Maximum Dose
- 5184 mg (maxTotalDoseAmount)
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