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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508804-39-00 | EU Trial (CTIS) Number | EU CT Number | |
| jRCT2031250519 | Registry Identifier | jRCT |
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The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.
In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 [NCT06100289]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.
During the study, participants will visit their study clinic several times.
The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term safety profile in pediatric participants who take vedolizumab SC.
The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289).
For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD):
This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort: Vedolizumab 108 mg PFS+AI | Experimental | Vedolizumab 108 mg, PFS+AI, subcutaneously, once every two weeks (Q2W) to the participants weighing greater than or equal to (>=) 30 kg and once every four weeks (Q4W) to the participants weighing >=10 to less than (<) 30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first. |
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| Treatment Cohort: Vedolizumab 108 mg PFS+NSD | Experimental | Vedolizumab 108 mg, PFS+NSD, subcutaneously, Q2W to the participants weighing >=30 kg and Q4W to the participants weighing >=10 to <30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first. |
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| Observational Cohort: Early Terminated Participants From Parent Study | Other | Participants who receive any dose of vedolizumab SC during the parent study VedolizumabSC-3003 (NCT06100289) and are not eligible for the treatment cohort of this extension study (that is, participants who early terminated from parent study VedolizumabSC-3003 [NCT06100289] or did not achieve clinical response in the parent study or who received corticosteroids in the last 4 weeks of the parent study) will only be observed in the observational cohort of this study and will not receive any dose of the vedolizumab SC in this cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab SC | Drug | Vedolizumab subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening. | First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138) |
| Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs) | AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions. | First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138) |
| Observational Cohort: Number of Participants With Prespecified Safety Events | Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery. | Up to Week 86 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events | Time to major IBD related events is defined as time to first occurrence of any among the 3 IBD related events such as: hospitalizations, surgeries, and procedures. | Up to Week 120 |
| Treatment Cohort: Change from Baseline in IMPACT-III Scores |
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Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) 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 participants with UC is defined as a reduction of partial Mayo score of >=2 points and >= 25 percentage (%) from baseline (from VedolizumabSC-3003 [NCT06100289]), 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 less than or equal to (<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) <=30 with a reduction in the PCDAI of >=15 points from baseline (from VedolizumabSC-3003 [NCT06100289]).
Inclusion Criteria for Observational Cohort
1. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.
Exclusion Criteria for Treatment Cohort
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital | Not yet recruiting | Phoenix | Arizona | 85016 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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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.
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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.
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| No Intervention | Other | As this is an observational cohort, no intervention will be administered. |
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IMPACT-III questionnaire will be administered to participants aged 9 to 17 years. The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert subscale score ranging from 1 to 5 for all answers. The outcome total score ranges from 35 to 175, with higher scores suggesting better quality of life. Baseline refers to the Baseline of study VedolizumabSC-3003 (NCT06100289). |
| Baseline, every 24 weeks in this study (up to Week 120) |
| Loma Linda University | Not yet recruiting | Loma Linda | California | 92350 | United States |
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| Children's Hospital of Orange County | Not yet recruiting | Orange | California | 92868 | United States |
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| Stanford Children's Health | Not yet recruiting | Palo Alto | California | 94304 | United States |
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| Advocate Children's Hospital Park Ridge | Not yet recruiting | Park Ridge | Illinois | 60068 | United States |
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| Childrens Hospital of Michigan | Not yet recruiting | Detroit | Michigan | 48201 | United States |
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| Atlantic Health - Morristown Medical Center | Not yet recruiting | Morristown | New Jersey | 07960 | United States |
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| New York Presbyterian Hospital | Not yet recruiting | New York | New York | 10029 | United States |
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| University Children's Clinic | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
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| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| The University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Penn State Health Milton South Hershey Medical Center | Not yet recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Medical University of South Carolina | Not yet recruiting | Charleston | South Carolina | 29425 | United States |
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| Multicare Health System Institute for Research and Innovation | Not yet recruiting | Tacoma | Washington | 98405 | United States |
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| Cliniques Universitaires Saint-Luc | Not yet recruiting | Brussels | Brussels Capital | Belgium |
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| Centre Hospitalier Chretien MontLegia | Not yet recruiting | Liège | Belgium |
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| UMHAT Sv. Georgi, EAD | Recruiting | Plovdiv | 4002 | Bulgaria |
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| Hvidovre Hospital | Not yet recruiting | Hvidovre | Capital Region | 2650 | Denmark |
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| Childrens Health Ireland at Crumlin - PIN | Not yet recruiting | Crumlin | Dublin | Ireland |
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| Azienda Ospedaliera Universitaria Gaetano Martino, Messina | Not yet recruiting | Messina | 98124 | Italy |
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| ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN | Not yet recruiting | Milan | Italy |
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| Unita Operativa Complessa Di Pediatria Medica | Not yet recruiting | Pescara | 65125 | Italy |
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| Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu | Not yet recruiting | Roma | 165 | Italy |
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| Kurume University Hospital | Not yet recruiting | Kurume-shi | Fukuoka | 830-0011 | Japan |
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| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
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| National Center for Child Health and Development | Not yet recruiting | Setagaya-ku | Tokyo | 157-8535 | Japan |
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| Radboud Universitair Medisch Centrum | Not yet recruiting | Nijmegen | 6525 GA | Netherlands |
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| Korczowski Bartosz, Gabinet Lekarski | Recruiting | Rzeszów | 35-302 | Poland |
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| WIP Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | 04-501 | Poland |
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| Instytut Pomnik - Centrum Zdrowia Dziecka | Recruiting | Warsaw | Poland |
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| SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego | Not yet recruiting | Zabrze | Poland |
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| Hospitais da Universidade de Coimbra | Not yet recruiting | Coimbra | 3000-602 | Portugal |
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| Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE | Not yet recruiting | Lisbon | 1649-035 | Portugal |
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| Centro Hospitalar do Porto - Hospital de Santo Antonio | Not yet recruiting | Porto | 4099-001 | Portugal |
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| Victor Gomoiu Clinical Hospital for Children | Recruiting | Bucharest | Bucharest | Romania |
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| Pius Brinzeu Emergency Clinical County Hospital | Not yet recruiting | Timișoara | Timiș County | Romania |
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| Grigore Alexandrescu Emergency Clinical Hospital for Children | Recruiting | Bucharest | Romania |
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| University Children's Clinic | Not yet recruiting | Belgrade | 11000 | Serbia |
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| Mother and Child Health Care Institute of Serbia Dr Vukan Cupic | Not yet recruiting | Belgrade | Serbia |
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| Institute for Children and Youth Health Care of Vojvodina | Not yet recruiting | Novi Sad | Serbia |
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| Kyungpook National University Chilgok hospital | Recruiting | Daegu | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
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| Samsung Medical Center | Not yet recruiting | Seoul | South Korea |
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| Hospital Arquitecto Marcide de Ferrol | Not yet recruiting | Ferrol | 15405 | Spain |
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| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario Virgen Macarena | Not yet recruiting | Seville | 41009 | Spain |
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| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) | Not yet recruiting | Valencia | 46026 | Spain |
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| University Hospital of Bern | Recruiting | Bern | 03010 | Switzerland |
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| Centre Hospitalier Universitaire Vaudois | Not yet recruiting | Lausanne | 1011 | Switzerland |
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| University Children's Hospital Zurich | Not yet recruiting | Zurich | 8032 | Switzerland |
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| Changhua Christian Medical Foundation - Changhua Christian Children's Hospital | Not yet recruiting | Changhua | 500010 | Taiwan |
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| Kaohsiung Medical University - Chung-Ho Memorial Hospital | Not yet recruiting | Kaohsiung City | 807 | Taiwan |
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| National Taiwan University Hospital | Not yet recruiting | Zhongzheng | 100 | Taiwan |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
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