Ulcerative ColitisPhase 3NCT06405087
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3 study testing Vedolizumab SC in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 47 sites in 14 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Vedolizumab SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 47 sitesin 14 countries
- Study dates
- 27 Oct 2025to 12 Aug 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
Trial locations and contacts
47 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 14 countries
United States13 sites, 13 recruiting
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Contact, 843-876-0444, suppa@musc.edu
Carmine Suppa
- Not yet recruiting
University Children's Clinic
Cleveland, Ohio, 44106
Site Contact, thomas.sferra@uhhospitals.org
Thomas Sferra
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Site Contact, kuroswski_j@ccf.org
Jacob Kuroswski
- Not yet recruiting
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Site Contact, 248-739-6054, dass1r@cmich.edu
Renee Dass
- Not yet recruiting
Penn State Health Milton South Hershey Medical Center
Hershey, Pennsylvania, 17033
Site Contact, sqg5835@psu.edu
Stefany Garrity
- Not yet recruiting
Loma Linda University
Loma Linda, California, 92350
Site Contact, kparashette@llu.edu
Kaylan Parashette
- Not yet recruiting
Atlantic Health - Morristown Medical Center
Morristown, New Jersey, 07960
Site Contact, alycia.leiby@atlantichealth.org
Alycia Leiby
- Not yet recruiting
New York Presbyterian Hospital
New York, New York, 10029
Site Contact, als9047@med.cornell.edu
Aliza Solomon
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Contact, Sirish-Palle@ouhsc.edu
Sirish Palle
- Not yet recruiting
Children's Hospital of Orange County
Orange, California, 92868
Site Contact, 714-509-4099, kgrant@choc.org
Kenneth Grant
- Not yet recruiting
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, 60068
Site Contact, kiran.gorla@aah.org
Kiranmai Gorla
- Not yet recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Contact, bpasternak@phoenixchildrens.com
Brad Pasternak
- Not yet recruiting
Multicare Health System Institute for Research and Innovation
Tacoma, Washington, 98405
Site Contact, 253-792-6630, ruvarier@multicare.org
Raghu Varier
Italy4 sites, 4 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Gaetano Martino, Messina
Messina, 98124
Site Contact, romanoc@unime.it
Claudio Romano
- Not yet recruiting
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN
Milan
Site Contact, 39 333 565 1596, francesca.penagini@asst-fbf-sacco.it
Francesca Penagini
- Not yet recruiting
Unita Operativa Complessa Di Pediatria Medica
Pescara, 65125
Site Contact, mariateresa.illiceto@asl.pe.it
Maria Illiceto
- Not yet recruiting
Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu
Roma, 165
Site Contact, paoladeangelis.opbg@gmail.com
Paola Angelis
South Korea4 sites, 4 recruiting
- Recruiting
Kyungpook National University Chilgok hospital
Daegu
Site Contact, geltbc@hanmail.net
Ben Kang
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Site Contact, ejlee7@yuhs.ac
Eunjoo Lee
- Recruiting
Seoul National University Hospital
Seoul, 3080
Site Contact, 82220723627, mjschj@snu.ac.kr
Jin Soo Moon
- Not yet recruiting
Samsung Medical Center
Seoul
Site Contact, smc_yhc@naver.com
Yon-Ho Choe
Spain4 sites, 4 recruiting
- Not yet recruiting
Hospital Arquitecto Marcide de Ferrol
Ferrol, 15405
Site Contact, ana.echarri.piudo@sergas.es
Ana Piudo
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Site Contact, enrique.medina@salud.madrid.org
Enrique Medina Benitez
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Site Contact, farguelles@telefonica.net
Federico Arguelles-Arias
- Not yet recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Site Contact, donat_est@gva.es
Ester Aliaga
Japan3 sites, 3 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Site Contact, t-kudo@juntendo.ac.jp
Takahiro Kudo
- Not yet recruiting
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Site Contact, mizuochi_tatsuki@kurume-u.ac.jp
Tatsuki Mizuochi
- Not yet recruiting
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535
Site Contact, arai-k@ncchd.go.jp
Katsuhiro Arai
Poland3 sites, 3 recruiting
- Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
Site Contact, korczowski@op.pl
Bartosz Korczowski
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Site Contact, m.meglicka@wip.waw.pl
Monika Meglicka
- Recruiting
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw
Site Contact, J.KIERKUS@IPCZD.PL
Jaroslaw Kierkus
Romania3 sites, 3 recruiting
- Recruiting
Victor Gomoiu Clinical Hospital for Children
Bucharest, Bucharest
Site Contact, iulia.tincu@umfcd.ro
Iulia Tincu
- Recruiting
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest
Site Contact, cbecheanu@yahoo.com
Cristina Becheanu
- Not yet recruiting
Pius Brinzeu Emergency Clinical County Hospital
Timișoara, Timiș County
Site Contact, pienar.corina@umft.ro
Corina Pienar
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital of Bern
Bern, 03010
Site Contact, 41 31 66 4 10 80, christiane.sokollik@insel.ch
Christiane Sokollik
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Site Contact, andreas.nydegger@chuv.ch
Andreas Nydegger
- Not yet recruiting
University Children's Hospital Zurich
Zurich, 8032
Site Contact, 41 44 266 3454, carsten.posovszky@kispi.uzh.ch
Carsten Posovszky
Taiwan3 sites, 3 recruiting
- Not yet recruiting
Changhua Christian Medical Foundation - Changhua Christian Children's Hospital
Changhua, 500010
Site Contact, meganegg@gmail.com
Fang_Ting Lu
- Not yet recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807
Site Contact, hsianghung@gmail.com
Hsiang-Hung Shih
- Not yet recruiting
National Taiwan University Hospital
Zhongzheng, 100
Site Contact, p93421001@ntu.edu.tw
Jia-Feng Wu
Belgium2 sites, 2 recruiting
- Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital
Site Contact, isabelle.scheers@uclouvain.be
Isabelle Scheers
- Not yet recruiting
Centre Hospitalier Chretien MontLegia
Liège
Site Contact, stephanie.colinet@chc.be
Stephanie Colinet
Serbia2 sites, 2 recruiting
- Not yet recruiting
University Children's Clinic
Belgrade, 11000
Site Contact, nina.ristic13@gmail.com
Nina Ristic
- Not yet recruiting
Institute for Children and Youth Health Care of Vojvodina
Novi Sad
Site Contact, drstojsic@gmail.com
Mirjana Stojsic
Bulgaria1 site, 1 recruiting
- Recruiting
UMHAT Sv. Georgi, EAD
Plovdiv, 4002
Site Contact, ivan.yankov@mu-plovdiv.bg
Ivan Yankov
Ireland1 site, 1 recruiting
- Not yet recruiting
Childrens Health Ireland at Crumlin - PIN
Crumlin, Dublin
Site Contact, seamus.hussey@ucd.ie
Seamus Hussey
Netherlands1 site, 1 recruiting
- Not yet recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Site Contact, gerard.damen@radboudumc.nl
Gerard Damen
About this study
Official title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
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.
Read the detailed description
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):
- Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI
- Treatment Cohort: Vedolizumab 108 mg 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).
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Vedolizumab SC, No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab SCDrug
Also called MLN0002
Vedolizumab subcutaneous injection.
No InterventionOther
As this is an observational cohort, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vedolizumab SC |
| 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. Receives: Drug: Vedolizumab SC |
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Week 86
Secondary outcomes (2)
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.
Measured: Up to Week 120
Treatment Cohort: Change from Baseline in IMPACT-III Scores
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).
Measured: Baseline, every 24 weeks in this study (up to Week 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start27 Oct 2025
- Primary completion12 Aug 2030 (estimated)
- Study completion12 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405087
- Sponsor's protocol ID
- VedolizumabSC-3004
- Other IDs
- 2023-508804-39-00, jRCT2031250519, 2023
- Status last verified
- Oct 2026
- First submitted
- 3 May 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.