Clinical trial • Phase III • Gastroenterology
Vedolizumab for Ulcerative colitis | Crohn's disease
Phase III trial of Vedolizumab for Ulcerative colitis | Crohn's disease. None/Not specified-controlled. 240 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis | Crohn's disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
None/Not specified-controlled Phase III trial in Poland, Croatia, Italy and others.
- Comparator
- None/Not specified
- Target Sample Size
- 240
- Trial Duration For Participant
- 1825
Eligibility
Recruits 240 paediatric patients.
- Pregnancy Exclusion
- Treatment Cohort only: The subject is female and is lactating or pregnant.
- Vulnerable Population
- The study enrolls pediatric subjects (<18 years). Informed consent must be signed and dated by the subject, the subject's legally authorized representative, parent, or legal guardian (adult caregiver) prior to any study procedures; pediatric assent forms are required as applicable. Age-specific assent/ICF materials are provided (examples listed in documents: picture book for under-6, assent forms for ages 6-11, 9-11, 12-14, 13-15, 16-17, parental ICFs and country-specific ICFs). The protocol notes subjects who reach adult age during the study may transition to commercial drug if available and per local regulation.
Inclusion criteria
- {"criterion_text":"- 1. 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.\n- 2. The subject, subject’s legally authorized representative or adult caregive signs and dates a written, informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.\n- The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age 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.).\n- The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for subjects with UC; or a reduction of PCDAI of ≥15 points for subjects with CD from baseline of the parent study and with total PCDAI ≤30.\n- 5. 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 or without spermicide) from signing of subject/ parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception.\n- 6. A female subject of childbearing potential who is sexually active with a nonsterilized 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 18 weeks after the last dose.\n- Main Criteria for Inclusion in the Observational Cohort: The subject, parent, or legal guardian signs and dates a written, informed consent form.\n- The subject has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study."}
Exclusion criteria
- {"criterion_text":"- Treatment Cohort only: The subject is female and is lactating or pregnant.\n- The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.\n- 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.\n- The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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.\n- The subject has other serious comorbidities that will limit their ability to complete the study.\n- The subject is unable to comply with all study assessments."}
Endpoints
Primary endpoints
- {"endpoint_text":"- For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs).","definition_or_measurement_approach":"Incidence measured as occurrence of adverse events (AEs) in the treatment cohort."}
- {"endpoint_text":"- For the Observational Cohort: Incidence of prespecified safety events (serious infections, malignancies, progressive multifocal leukoencephalopathy [PML], concerns about growth and pubertal development, and bowel surgery).","definition_or_measurement_approach":"Incidence measured as occurrence of prespecified safety events (serious infections, malignancies, PML, growth/puberty concerns, and bowel surgery) in the observational cohort."}
Secondary endpoints
- {"endpoint_text":"- For the Treatment Cohort: • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures).","definition_or_measurement_approach":"Time-to-event measurement (time from baseline to major IBD-related event such as hospitalization, surgery, or procedure)."}
- {"endpoint_text":"- For the Treatment Cohort: • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks.","definition_or_measurement_approach":"Changes from parent-study baseline in IMPACT-III total and subscale scores assessed every 24 weeks for subjects aged 9–17 years."}
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent must be signed and dated by the subject, the subject's legally authorized representative, or parent/legal guardian (adult caregiver) prior to any study procedures; pediatric assent forms are required as applicable. Age-specific participant information and assent/ICF documents are provided (examples: picture book for under-6, assent forms for ages 6–11, 9–11, 12–14, 13–15, 16–17; parental ICFs). Country-specific recruitment and ICF/recruitment arrangements documents are provided for participating countries.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 128
Poland
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 32
- Number Of Sites
- 7
- Number Of Participants
- 70
Sites
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- WIP Warsaw IBD Point Profesor Kierkuś
- Principal Investigator Name
- Monika Meglicka
- Principal Investigator Email
- m.meglicka@wip.waw.pl
- Contact Person Name
- Monika Meglicka
- Contact Person Email
- m.meglicka@wip.waw.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Gastroenterologii, Alergologii i Pediatrii
- Principal Investigator Name
- Elżbieta Czkwianianc
- Principal Investigator Email
- elzbieta.czkwianianc@iczmp.edu.pl
- Contact Person Name
- Elżbieta Czkwianianc
- Contact Person Email
- elzbieta.czkwianianc@iczmp.edu.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
- j.kierkus@med-net.pl
- Contact Person Name
- Jarosław Kierkuś
- Contact Person Email
- j.kierkus@med-net.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
- Uniwersytecki Szpital Dzieciecy W Krakowie
- Department Name
- Klinika Pediatrii, Gastroenterologii i Żywienia
- Principal Investigator Name
- Kinga Kowalska-Duplaga
- Principal Investigator Email
- kingakd@mp.pl
- Contact Person Name
- Kinga Kowalska-Duplaga
- Contact Person Email
- kingakd@mp.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- gawdis@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- gawdis@twojaprzychodnia.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Uniwersyteckie Centrum Pediatrii M.Konopnickiej,Klinika Alergologii,Gastroenterologii i Zywienia
- Principal Investigator Name
- Ewa Toporowska-Kowalska
- Principal Investigator Email
- etka@op.pl
- Contact Person Name
- Ewa Toporowska-Kowalska
- Contact Person Email
- etka@op.pl
Croatia
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Klinika Za Djecje Bolesti Zagreb
- Department Name
- Department of Pediatric Gastroenterology, Hepatology and Eating Disorders
- Principal Investigator Name
- Iva Hojsak
- Principal Investigator Email
- gastro.dijagnostika@kdb.hr
- Contact Person Name
- Iva Hojsak
- Contact Person Email
- gastro.dijagnostika@kdb.hr
Italy
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 05-08-2024
- Processing Time Days
- 33
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- SOC Gastroenterologia e Nutrizione
- Principal Investigator Name
- PAOLO LIONETTI
- Principal Investigator Email
- paolo.lionetti@unifi.it
- Contact Person Name
- PAOLO LIONETTI
- Contact Person Email
- paolo.lionetti@unifi.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- UOC Pediatria – Gastroenterologia Pediatrica
- Principal Investigator Name
- PATRIZIA ALVISI
- Principal Investigator Email
- patrizia.alvisi@ausl.bologna.it
- Contact Person Name
- PATRIZIA ALVISI
- Contact Person Email
- patrizia.alvisi@ausl.bologna.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UO Pediatria Dipartimento della Donna e del Bambino - Chirurgia Generale Specialistica
- Principal Investigator Name
- CATERINA STRISCIUGLIO
- Principal Investigator Email
- CATERINA.STRISCIUGLIO@unicampania.it
- Contact Person Name
- CATERINA STRISCIUGLIO
- Contact Person Email
- CATERINA.STRISCIUGLIO@unicampania.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Endoscopia Interventistica Clinica Pediatrica
- Principal Investigator Name
- ROBERTO PANCERI
- Principal Investigator Email
- r.panceri@asst-monza.it
- Contact Person Name
- ROBERTO PANCERI
- Contact Person Email
- r.panceri@asst-monza.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Unità di Endoscopia e Motilità Digestiva Pediatrica
- Principal Investigator Name
- ERASMO MIELE
- Principal Investigator Email
- erasmo.miele@unina.it
- Contact Person Name
- ERASMO MIELE
- Contact Person Email
- erasmo.miele@unina.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- UOC Gastroenterologia ed Epatologia Pediatrica
- Principal Investigator Name
- Salvatore Oliva
- Principal Investigator Email
- salvatore.oliva@uniroma1.it
- Contact Person Name
- Salvatore Oliva
- Contact Person Email
- salvatore.oliva@uniroma1.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
- Department Name
- Velkey Lászlo Gyermek Egészségügyi Központ
- Principal Investigator Name
- Erzsébet Szakos
- Principal Investigator Email
- szakos.iiigyek@bazmkorhaz.hu
- Contact Person Name
- Erzsébet Szakos
- Contact Person Email
- szakos.iiigyek@bazmkorhaz.hu
- Site Name
- Semmelweis University
- Department Name
- I. Sz. Gyermekgyógyászati Klinika
- Principal Investigator Name
- Aron Cseh
- Principal Investigator Email
- cseharon@gmail.com
- Contact Person Name
- Aron Cseh
- Contact Person Email
- cseharon@gmail.com
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- Natália Lásztity
- Principal Investigator Email
- laszity.clinexpert@gmail.com
- Contact Person Name
- Natália Lásztity
- Contact Person Email
- laszity.clinexpert@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 30-07-2024
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- UZ Leuven
- Department Name
- Pediatric Gastoenterology
- Principal Investigator Name
- Ilse Hoffman
- Principal Investigator Email
- ilse.hoffman@uzleuven.be
- Contact Person Name
- Ilse Hoffman
- Contact Person Email
- ilse.hoffman@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Pediatric Gastoenterology
- Principal Investigator Name
- Els Van de Vijver
- Principal Investigator Email
- Els.vandevijver@uza.be
- Contact Person Name
- Els Van de Vijver
- Contact Person Email
- Els.vandevijver@uza.be
- Site Name
- UZ Brussel
- Department Name
- Pediatric Gastoenterology
- Principal Investigator Name
- Elisabeth De Greef
- Principal Investigator Email
- Elisabeth.degreef@uzbrussel.be
- Contact Person Name
- Elisabeth De Greef
- Contact Person Email
- Elisabeth.degreef@uzbrussel.be
Greece
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 01-08-2024
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- University General Hospital Attikon
- Department Name
- C' Pediatric Clinic of the University of Athens, Unit Pediatric gastroenterology
- Principal Investigator Name
- Smaragdi Fessatou
- Principal Investigator Email
- sfessatou@yahoo.gr
- Contact Person Name
- Smaragdi Fessatou
- Contact Person Email
- sfessatou@yahoo.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- C' Pediatric Clinic of AUTh
- Principal Investigator Name
- Ioannis Xynias
- Principal Investigator Email
- xinias@auth.gr
- Contact Person Name
- Ioannis Xynias
- Contact Person Email
- xinias@auth.gr
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- A' Pediatric Clinic of the University of Athens and Gastroenterology Department
- Principal Investigator Name
- Alexandra Papadopoulou
- Principal Investigator Email
- a.papadopoulou@paidon-agiasofia.gr
- Contact Person Name
- Alexandra Papadopoulou
- Contact Person Email
- a.papadopoulou@paidon-agiasofia.gr
Sponsor
Primary sponsor
- Full Name
- Takeda Development Center Americas Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- multiple sponsor duties including operational and clinical trial support (codes:1,10,11,12,13,14,2,3,4,5,6,7,8,9)
- Name
- PPD International Holdings LLC
- Responsibilities
- Specialty testing (Bulhmann Calprotectin)
- Name
- PPD Global Ltd.
- Responsibilities
- operational and clinical support (codes:1,10,11,12,2,3,6,7,8,9)
- Name
- Q Squared Solutions LLC / Q Squared Solutions Limited
- Responsibilities
- laboratory testing and sample management (Ova and parasites; Micro - C Difficle PCR; TB and samples management)
- Name
- QPS LLC
- Responsibilities
- PK and speciality testing (AVA, nAVA)
- Name
- Medidata Solutions Inc.
- Responsibilities
- data platform responsibilities (code:7)
Third parties
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,10,11,12,13,14,2,3,4,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"15: Ova and parasites (fecal sample)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"15: Specialty testing (Bulhmann Calprotectin)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"15: Micro - C Difficle PCR (fecal sample)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"15: TB and samples management","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"15: PK, speciality testing (AVA, nAVA)","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes:1,10,11,12,2,3,6,7,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Entyvio 300 mg powder for concentrate for solution for infusion
- Active Substance
- Vedolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/14/923/001)
- Starting Dose
- Same blinded dose as received at Week 46 of parent study (weight-based groups: see dose_levels)
- Dose Levels
- Participants 10 to ≤15 kg: Vedolizumab 150 mg (High dose) or 100 mg (Low dose); Participants >15 to <30 kg: Vedolizumab 200 mg (High dose) or 100 mg (Low dose); Participants ≥30 kg: Vedolizumab 300 mg (High dose) or 150 mg (Low dose)
- Frequency
- Once every 8 weeks (Q8W)
- Maximum Dose
- 300 mg (maxDailyDoseAmount)
- Investigational Product Name
- PREDNISONE
- Active Substance
- Prednisone
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Marketed product
- Maximum Dose
- 40 mg daily (maxDailyDoseAmount)
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