Actively Recruiting
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Led by Takeda · Updated on 2026-05-06
70
Participants Needed
57
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant weighs at least 10 kg at screening and enrollment
- Diagnosed with ulcerative colitis or Crohn's disease at least 1 month before screening
- For ulcerative colitis: Modified Mayo score between 5 and 9 with specific endoscopic findings
- For Crohn's disease: Pediatric Crohn's disease activity index greater than 30 and endoscopic score above defined thresholds
- History of failed, lost response to, or intolerance of corticosteroids, immunomodulators, or TNF-alpha antagonist therapy
- Evidence of ulcerative colitis extending beyond the rectum
- Participants with long-duration colitis must have a negative surveillance colonoscopy within 12 months before screening
- Up-to-date vaccinations according to the local childhood vaccine schedule
You will not qualify if you...
- Prior exposure to anti-integrins such as natalizumab, efalizumab, etrolizumab, abrilumab, MAdCAM-1 antagonists, or rituximab
- Previous treatment with vedolizumab
- Allergy or hypersensitivity to vedolizumab or its ingredients
- Active or history of serious neurological diseases including progressive multifocal leukoencephalopathy
- Receipt of any live vaccination within 30 days before first study dose
- Current or anticipated need for surgery for ulcerative colitis or Crohn's disease during the study
- History of certain surgeries including subtotal or total colectomy, or presence of intestinal stomas or pouches
- Diagnosis of indeterminate colitis
- Signs suggesting monogenic very early-onset inflammatory bowel disease
- Active or latent tuberculosis
- Positive hepatitis B surface antigen or core antibody tests; immune subjects may be included
- Known immunodeficiency conditions including HIV infection or organ transplant
- Positive stool tests for ova, parasites, or cultures
- Positive Clostridioides difficile stool test at screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 57 locations
1
VVCRD Clinical Research
Garden Grove, California, United States, 92845-2006
Terminated
2
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
Active, Not Recruiting
3
Children's Hospital Of Orange County
Orange, California, United States, 92868
Active, Not Recruiting
4
Stanford Children's Health
Palo Alto, California, United States, 94304
Active, Not Recruiting
5
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
Active, Not Recruiting
6
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Atlantic Health System
Morristown, New Jersey, United States, 07960
Active, Not Recruiting
8
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States, 10065
Active, Not Recruiting
9
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
10
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Active, Not Recruiting
11
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
Active, Not Recruiting
12
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
13
Centre Hospitalier Chretien MontLegia
Liège, Belgium, 4000
Active, Not Recruiting
14
University Hospital "Saint George"
Plovdiv, Bulgaria, 4002
Active, Not Recruiting
15
Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EAD
Sofia, Bulgaria, 1606
Active, Not Recruiting
16
Hvidovre University Hospital
Hvidovre, Capital Region, Denmark, 2650
Active, Not Recruiting
17
H.C Andersens Hospital
Odense, Denmark, 5000
Active, Not Recruiting
18
Childrens Health Ireland
Dublin, Ireland, D12 N512
Active, Not Recruiting
19
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Messina, Italy, 98124
Active, Not Recruiting
20
V. Buzzi Hospital
Milan, Italy, 20154
Active, Not Recruiting
21
Unita Operativa Complessa Di Pediatria Medica
Pescara, Italy, 65125
Active, Not Recruiting
22
IRCCS Ospedale Pediatrico Bambino Gesu
Rome, Italy, 00165
Active, Not Recruiting
23
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Active, Not Recruiting
24
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
25
National Center for Child Health and Development (NCCHD)
Setagaya-Ku, Tokyo, Japan, 157-8535
Active, Not Recruiting
26
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Active, Not Recruiting
27
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland, 04730
Actively Recruiting
28
Uniwersytecki Szpital Dzieciecy W Krakowie
Krakow, Poland, 30-663
Active, Not Recruiting
29
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland, 35302
Actively Recruiting
30
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 04-501
Actively Recruiting
31
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
Zabrze, Poland, 41-800
Active, Not Recruiting
32
Hospital Pediatrico - Unidade Local de Saude de Coimbra
Coimbra, Portugal, 3000-602
Active, Not Recruiting
33
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, Portugal, 1649-035
Active, Not Recruiting
34
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio
Porto, Portugal, 4050-165
Active, Not Recruiting
35
"Emergency County Clinical Hospital ""Pius Brinzeu"""
Timișoara, Timiș County, Romania, 300226
Active, Not Recruiting
36
Dr Victor Gomoiu Clinical Children Hospital
Bucharest, Romania, 022102
Actively Recruiting
37
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,
Bucharest, Romania, 11743
Actively Recruiting
38
University Children's Hospital
Belgrade, Serbia, 11000
Actively Recruiting
39
Mother and child helath care Institute of Serbia dr Vukan Cupic
Belgrade, Serbia, 11070
Active, Not Recruiting
40
Institute for Childand YouthHealth Care of Vojvodina
Novi Sad, Serbia, 21000
Active, Not Recruiting
41
Kyungpook National University Chilgok Hospital (KNUCH)
Daegu, South Korea, 41404
Active, Not Recruiting
42
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
43
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
44
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
45
Complejo Hospitalario Universitario de Ferrol
Ferrol, Spain, 15405
Active, Not Recruiting
46
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Active, Not Recruiting
47
Hospital U. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
48
Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain
Valencia, Spain, 46026
Active, Not Recruiting
49
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Active, Not Recruiting
50
Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus
Bern, Switzerland, 3010
Active, Not Recruiting
51
Universitats-Kinderspital
Zurich, Switzerland, 8008
Actively Recruiting
52
National Taiwan University Children's Hospital
Taipei, Zhongzheng Dist, Taiwan, 100
Actively Recruiting
53
Changhua Christian Hospital
Changhua, Taiwan, 500010
Active, Not Recruiting
54
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Active, Not Recruiting
55
Koc University Hospital
Istanbul, Zeytinburnu, Turkey (Türkiye), 34010
Suspended
56
Istanbul University, Istanbul Medical Faculty
Istanbul, Turkey (Türkiye), 34093
Suspended
57
Dokuz Eylul University Medical Faculty
Izmir, Turkey (Türkiye), 35340
Suspended
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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