Ulcerative ColitisPhase 3NCT06100289
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
A Phase 3 study testing Vedolizumab IV and Vedolizumab SC in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 54 sites in 16 countries.
Trial summary
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. 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 IV and 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
- 54 sitesin 16 countries
- Study dates
- 22 Jan 2025to 16 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- The participant weighs ≥10 kg at the time of screening and enrollment into the study.
- 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.
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab).
- Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
- 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.
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Who cannot join
- 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.
- Participants who have had prior exposure to vedolizumab.
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
- The participant has received any live vaccinations within 30 days before first dose of study drug.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
Show all 14Show fewer
- 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.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
- Participants with active or latent tuberculosis (TB).
- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody [anti-HBs]-positive) may, however, be included.
- The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
Trial locations and contacts
54 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 16 countries
United States14 sites, 6 recruiting
- Active, not recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Site Contact, 313-745-5585, kcares@dmc.org
Kristen Cares
- Active, not recruiting
Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine
Hershey, Pennsylvania, 17033
- Active, not recruiting
Loma Linda University School of Medicine
Loma Linda, California, 92354
- Active, not recruiting
Atlantic Health System
Morristown, New Jersey, 07960
- Active, not recruiting
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10065
- Not yet recruiting
Medical University of South Carolina
North Charleston, South Carolina, 29406
Site Contact, 843-876-0444, suppa@musc.edu
Carmine Suppa
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Contact, 405-271-5312, Sirish-Palle@ouhsc.edu
Sirish Palle
- Recruiting
Children's Hospital Of Orange County
Orange, California, 92868
Site Contact, 714-509-4099, kgrant@choc.org
Kenneth Grant
- Active, not recruiting
Stanford Children's Health
Palo Alto, California, 94304
- Active, not recruiting
Advocate Children's Hospital
Park Ridge, Illinois, 60068
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Site Contact, 602-933-0674, bpasternak@phoenixchildrens.com
Brad Pasternak
- Not yet recruiting
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Site Contact, 253-792-6630, ruvarier@multicare.org
Raghu Varier
Italy4 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Messina, 98124
Site Contact, 385779702, claudio.romano@unime.it
Claudio Romano
- Recruiting
V. Buzzi Hospital
Milan, 20154
Site Contact, 0039- 02/63635329, gianvincenzo.zuccotti@unimi.it
Gian Vincenzo Zuccotti
- Active, not recruiting
Unita Operativa Complessa Di Pediatria Medica
Pescara, 65125
- Active, not recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Rome, 00165
Poland4 sites, 3 recruiting
- Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35302
Site Contact, 604481752, korczowski@op.pl
Bartosz Korczowski
- Recruiting
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, 04730
Site Contact, 48500111648, j.kierkus@wipw.waw.pl
Jaroslaw Kierkus
- Recruiting
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Site Contact, 603-508-908, m.meglicka@wip.waw.pl
Monika Meglicka
- Active, not recruiting
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
Zabrze, 41-800
South Korea4 sites, 4 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital (KNUCH)
Daegu, 41404
Site Contact, 82-53-200-3780, benkang@knu-ac.kr
Ben Kang
- Recruiting
Seoul National University Hospital
Seoul, 03080
Site Contact, 82220723627, mjschj@snu.ac.kr
Jin Soo Moon
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Site Contact, 82 2 2228 5924, ejlee7@yuhs.ac
Eunjoo Lee
- Recruiting
Samsung Medical Center
Seoul, 06351
Site Contact, - +82-2-3410-3539, yonho.choe@samsung.com
Yon Ho Choe
Spain4 sites, 1 recruiting
- Active, not recruiting
Complejo Hospitalario Universitario de Ferrol
Ferrol, 15405
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital U. Virgen Macarena
Seville, 41009
Site Contact, 617348501, farguelles@telefonica.net
Federico Arguelles
- Active, not recruiting
Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain
Valencia, 46026
Japan3 sites, 1 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Site Contact, +81-3-3813-3111, t-kudo@juntendo.ac.jp
Takahiro Kudo
- Active, not recruiting
Kurume University Hospital
Kurume, Fukuoka, 830-0011
- Active, not recruiting
National Center for Child Health and Development (NCCHD)
Setagaya-Ku, Tokyo, 157-8535
Portugal3 sites, 1 recruiting
- Active, not recruiting
Hospital Pediatrico - Unidade Local de Saude de Coimbra
Coimbra, 3000-602
- Recruiting
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, 1649-035
Site Contact, 917513045, helena.d.s.loreto@gmail.com
Maria Helena Loreto
- Active, not recruiting
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio
Porto, 4050-165
Romania3 sites, 2 recruiting
- Recruiting
Dr Victor Gomoiu Clinical Children Hospital
Bucharest, 022102
Site Contact, 0040725535100, if_boian@yahoo.com
Iulia Florentina Tincu
- Recruiting
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,
Bucharest, 11743
Site Contact, 40722882898, cbecheanu@yahoo.com
Cristina Becheanu
- Active, not recruiting
"Emergency County Clinical Hospital ""Pius Brinzeu"""
Timișoara, Timiș County, 300226
Serbia3 sites, 1 recruiting
- Recruiting
University Children's Hospital
Belgrade, 11000
Site Contact, 00 381 11 20 60 700, nina.ristic13@gmail.com
Nina Ristic
- Active, not recruiting
Mother and child helath care Institute of Serbia dr Vukan Cupic
Belgrade, 11070
- Active, not recruiting
Institute for Childand YouthHealth Care of Vojvodina
Novi Sad, 21000
Switzerland3 sites, 3 recruiting
- Recruiting
Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus
Bern, 3010
Site Contact, +41 31 66 4 10 80, christiane.sokollik@insel.ch
Christiane Sokollik
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Site Contact, +41213143308, andreas.nydegger@chuv.ch
Andreas Nydegger
- Recruiting
Universitats-Kinderspital
Zurich, 8008
Site Contact, 0041 44 249 66 67, carsten.posovszky@kispi.uzh.ch
Carsten Posovszky
Taiwan3 sites, 2 recruiting
- Active, not recruiting
Changhua Christian Hospital
Changhua, 500010
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Site Contact, +886-0912168512, hsianghung@gmail.com
Hsiang-Hung Shih
- Recruiting
National Taiwan University Children's Hospital
Taipei, Zhongzheng Dist, 100
Site Contact, +886 2 23123456 #271718, wjf@ntu.edu.tw
Jia-Feng Wu
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Site Contact, 3227641387, isabelle.scheers@saintluc.uclouvain.be
Isabelle Scheers
- Recruiting
Centre Hospitalier Chretien MontLegia
Liège, 4000
Site Contact, 32 43554214, olivia.bauraind@chc.be
Olivia Bauraind
Bulgaria1 site, 1 recruiting
- Recruiting
University Hospital "Saint George"
Plovdiv, 4002
Site Contact, 35932602542, ivan.yankov@mu-plovdiv.bg
Ivan Yankov
Denmark1 site
- Active, not recruiting
Hvidovre University Hospital
Hvidovre, Capital Region, 2650
Netherlands1 site
- Active, not recruiting
Radboud University Medical Center
Nijmegen, 6525 GA
About this study
Official title: An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
Read the detailed description
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab.
The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as:
- Participants ≥30 kilograms (kg), Vedolizumab (High Dose)
- Participants >15 to <30 kg, Vedolizumab (Medium Dose)
- Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose)
At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period:
- Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W)
- Participants ≥10 to <30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W)
This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Vedolizumab IV, Vedolizumab SC
- 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 IVDrug
Also called ENTYVIO, KYNTELES, MLN0002
Vedolizumab IV injection.
Vedolizumab SCDrug
Also called MLN0002SC
Vedolizumab SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV | Experimental | Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Receives: Drug: Vedolizumab IV |
| Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV | Experimental | Participants weighing >15 to <30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Receives: Drug: Vedolizumab IV |
| Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV | Experimental | Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Receives: Drug: Vedolizumab IV |
| Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W | Experimental | Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period. Receives: Drug: Vedolizumab SC |
| Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W | Experimental | Participants with clinical response at Week 14 weighing ≥10 to <30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period. Receives: Drug: Vedolizumab SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Measured: Predose at Week 34
Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34
Measured: Multiple time points prior to Week 34; pre-dose at Week 34
Secondary outcomes (2)
Percentage of Participants with Positive Antivedolizumab Antibody (AVA)
Measured: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Percentage of Participants with Positive Neutralizing AVA
Measured: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start22 Jan 2025
- Primary completion16 May 2028 (estimated)
- Study completion16 May 2028 (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
- Non-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
- NCT06100289
- Sponsor's protocol ID
- VedolizumabSC-3003
- Other IDs
- 2023-503188-40-00, jRCT2071240072, 2023
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2023
- Last updated
- 3 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
- ClinicalTrials.gov ID
- NCT06100289
- Acronym / sponsor ID
- VedolizumabSC-3003
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 16 May 2028 (estimated)
- Study completion
- 16 May 2028 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
Detailed description
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab.
The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as:
- Participants ≥30 kilograms (kg), Vedolizumab (High Dose)
- Participants >15 to <30 kg, Vedolizumab (Medium Dose)
- Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose)
At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period:
- Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W)
- Participants ≥10 to <30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W)
This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV | Experimental | Drug: Vedolizumab IVParticipants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. |
| Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV | Experimental | Drug: Vedolizumab IVParticipants weighing >15 to <30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. |
| Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV | Experimental | Drug: Vedolizumab IVParticipants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. |
| Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W | Experimental | Drug: Vedolizumab SCParticipants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period. |
| Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W | Experimental | Drug: Vedolizumab SCParticipants with clinical response at Week 14 weighing ≥10 to <30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The participant weighs ≥10 kg at the time of screening and enrollment into the study.
- Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab).
- Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
- 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.
Key exclusion criteria (14 listed)
- 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.
- Participants who have had prior exposure to vedolizumab.
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
- The participant has received any live vaccinations within 30 days before first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab IVAlso: ENTYVIO, KYNTELES, MLN0002Vedolizumab IV injection. | Drug | Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV, Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV, Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV |
| Vedolizumab SCAlso: MLN0002SCVedolizumab SC injection. | Drug | Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W, Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W |
Primary outcome
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
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
2 secondary outcomes
Percentage of Participants with Positive Antivedolizumab Antibody (AVA)
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Percentage of Participants with Positive Neutralizing AVA
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
54 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vedolizumab IV and Vedolizumab SC in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 54 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Italy, Poland, South Korea, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.