A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
NCT ID: NCT06100289
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2025-01-22
2027-06-30
Brief Summary
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The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV
Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Vedolizumab IV
Vedolizumab IV injection.
Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV
Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Vedolizumab IV
Vedolizumab IV injection.
Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV
Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Vedolizumab IV
Vedolizumab IV injection.
Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W
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.
Vedolizumab SC
Vedolizumab SC injection.
Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W
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.
Vedolizumab SC
Vedolizumab SC injection.
Interventions
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Vedolizumab IV
Vedolizumab IV injection.
Vedolizumab SC
Vedolizumab SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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).
4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
5. 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.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Exclusion Criteria
2. Participants who have had prior exposure to vedolizumab.
3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
5. The participant has received any live vaccinations within 30 days before first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
7. 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.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
10. Participants with active or latent tuberculosis (TB).
11. 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.
12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
2 Years
17 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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VVCRD Clinical Research
Garden Grove, California, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Children's Hospital Of Orange County
Orange, California, United States
Stanford Children's Health
Palo Alto, California, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Atlantic Health System
Morristown, New Jersey, United States
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Centre Hospitalier Chretien MontLegia
Liège, , Belgium
University Hospital "Saint George"
Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EAD
Sofia, , Bulgaria
Hvidovre University Hospital
Hvidovre, Capital Region, Denmark
H.C Andersens Hospital
Odense, , Denmark
Childrens Health Ireland
Dublin, , Ireland
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Messina, , Italy
V. Buzzi Hospital
Milan, , Italy
Unita Operativa Complessa Di Pediatria Medica
Pescara, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Kurume University Hospital
Kurume, Fukuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development (NCCHD)
Setagaya-Ku, Tokyo, Japan
Radboud University Medical Center
Nijmegen, , Netherlands
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Dzieciecy W Krakowie
Krakow, , Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
Zabrze, , Poland
Hospital Pediatrico - Unidade Local de Saude de Coimbra
Coimbra, , Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, , Portugal
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio
Porto, , Portugal
"Emergency County Clinical Hospital ""Pius Brinzeu"""
Timișoara, Timiș County, Romania
Dr Victor Gomoiu Clinical Children Hospital
Bucharest, , Romania
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,
Bucharest, , Romania
University Children's Hospital
Belgrade, , Serbia
Mother and child helath care Institute of Serbia dr Vukan Cupic
Belgrade, , Serbia
Institute for Childand YouthHealth Care of Vojvodina
Novi Sad, , Serbia
Kyungpook National University Chilgok Hospital (KNUCH)
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Complejo Hospitalario Universitario de Ferrol
Ferrol, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital U. Virgen Macarena
Seville, , Spain
Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain
Valencia, , Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus
Bern, , Switzerland
Universitats-Kinderspital
Zurich, , Switzerland
National Taiwan University Children's Hospital
Taipei, Zhongzheng Dist, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Koc University Hospital
Istanbul, Zeytinburnu, Turkey (Türkiye)
Istanbul University, Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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.
Other Identifiers
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2023-503188-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2071240072
Identifier Type: REGISTRY
Identifier Source: secondary_id
VedolizumabSC-3003
Identifier Type: -
Identifier Source: org_study_id
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