Actively Recruiting
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Led by Takeda · Updated on 2026-05-07
240
Participants Needed
98
Research Sites
507 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
CONDITIONS
Official Title
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Treatment Cohort: Completed parent study MLN0002-3024 or MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54
- For Treatment Cohort: Male participants who are sexually active with a female partner of childbearing potential must agree to use barrier contraception during and 18 weeks after the study
- For Treatment Cohort: Female participants of childbearing potential who are sexually active with a nonsterilized male partner must agree to use highly effective contraception during and 18 weeks after the study
- For Observational Cohort: Received at least 1 dose of vedolizumab in the parent study and either terminated early or completed Week 54 visit but not eligible for Treatment Cohort
You will not qualify if you...
- For Treatment Cohort: Requires or expects to require major surgery for UC or CD during the study
- For Treatment Cohort: Developed new unstable or uncontrolled serious medical disorders that may affect study results or safety
- For Treatment Cohort: Has serious comorbidities limiting ability to complete the study
- For Treatment Cohort: Unable to comply with all study assessments
- For Treatment Cohort: Hypersensitivity or allergies to vedolizumab or its excipients
- For Treatment Cohort: Is pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
University of South Alabama (USA) Physicians Group
Mobile, Alabama, United States, 36604
Not Yet Recruiting
2
Phoenix Childrens Hospital - Thomas Rd - PIN
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Cedars Sinai Medical Center - 127 San Vicente Blvd
Los Angeles, California, United States, 90048
Withdrawn
4
Rady Children's Hospital - San Diego - PIN
San Diego, California, United States, 92123
Not Yet Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94158
Withdrawn
6
I.H.S Health LLC-Kissimmee-445 W Oak St
Kissimmee, Florida, United States, 34741
Withdrawn
7
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
8
Advocate Children's Hospital - Park Ridge - PIN
Park Ridge, Illinois, United States, 60068
Actively Recruiting
9
Riley Hospital For Children - PIN
Indianapolis, Indiana, United States, 46202
Withdrawn
10
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Withdrawn
11
Boston Children's Hospital - PIN
Boston, Massachusetts, United States, 02215
Withdrawn
12
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States, 55413
Terminated
13
Mayo Clinic - PIN
Rochester, Minnesota, United States, 55905
Terminated
14
Goryeb Children's Hospital
Morristown, New Jersey, United States, 07960
Terminated
15
Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN
New Hyde Park, New York, United States, 11042
Withdrawn
16
University of Rochester Medical Center - PPDS
Rochester, New York, United States, 14642
Withdrawn
17
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Withdrawn
18
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
19
UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN
Pittsburgh, Pennsylvania, United States, 15201
Withdrawn
20
Hasbro Children's Hospital - PIN
Providence, Rhode Island, United States, 02903
Withdrawn
21
Texas Children's Hospital - Baylor - PIN
Houston, Texas, United States, 77030
Not Yet Recruiting
22
Carilion Children's Tanglewood Center
Roanoke, Virginia, United States, 24018
Actively Recruiting
23
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
24
Queensland Childrens Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
25
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
26
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia, 3052
Actively Recruiting
27
UZ Antwerpen - PIN
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
28
UZ Brussel - PIN
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
29
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
30
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Withdrawn
31
British Columbia Children's Hospital - 4480 Oak St
Vancouver, British Columbia, Canada, V6H 3N1
Withdrawn
32
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada, N6A 5W9
Terminated
33
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Withdrawn
34
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, China, 100045
Not Yet Recruiting
35
Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus
Zhengzhou, Henan, China, 450018
Actively Recruiting
36
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Actively Recruiting
37
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
38
The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
39
Children's Hospital Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
40
University Hospital Center Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Withdrawn
41
University Hospital of Split-Spinciceva 1
Split, Croatia, 21000
Withdrawn
42
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, Czechia, 100 34
Withdrawn
43
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, Czechia, 140 00
Withdrawn
44
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Athens, Attica, Greece, 12462
Actively Recruiting
45
Children's Hospital Agia Sofia
Athens, Greece, GR11527
Actively Recruiting
46
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece, 546 42
Withdrawn
47
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece, 546 42
Actively Recruiting
48
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
Actively Recruiting
49
Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, Hungary, 6720
Withdrawn
50
Clinexpert Obuda Egeszsegcentruma
Budapest, Hungary, 1033
Terminated
51
Semmelweis Egyetem, Pulmonologiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
52
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Jerusalem, Jerusalem, Israel, 90000
Actively Recruiting
53
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel, 91031
Actively Recruiting
54
Soroka University Medical Centre
Beersheba, Israel, 84101
Withdrawn
55
Rambam Health Care Campus PPDS
Haifa, Israel, 31096
Actively Recruiting
56
Carmel Medical Center
Haifa, Israel, 34362
Actively Recruiting
57
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Israel, 91120
Actively Recruiting
58
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Israel, 49100
Terminated
59
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
60
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2
Naples, Campania, Italy, 80131
Actively Recruiting
61
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy, 40133
Actively Recruiting
62
Sapienza University of Rome
Rome, Lazio, Italy, 185
Actively Recruiting
63
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Terminated
64
Azienda Ospedaliero Universitaria A Meyer
Florence, Tuscany, Italy, 50139
Terminated
65
Universita degli Studi di Padova
Padova, Veneto, Italy, 35122
Withdrawn
66
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan, 830-0011
Actively Recruiting
67
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan, 861-8520
Actively Recruiting
68
Saitama Children's Medical Center-1397-1 yamane
Hidaka, Saitama, Japan, 330-8777
Actively Recruiting
69
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8431
Actively Recruiting
70
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan, 157-8535
Actively Recruiting
71
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, Lithuania, LT-50161
Withdrawn
72
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, Lithuania, 8406
Withdrawn
73
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 30-663
Actively Recruiting
74
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4
Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
Withdrawn
75
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland, 04-501
Actively Recruiting
76
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland, 04-736
Actively Recruiting
77
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
Actively Recruiting
78
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Withdrawn
79
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, Poland, 40-752
Withdrawn
80
Twoja Przychodnia SCM - Slowackiego
Szczecin, West Pomeranian Voivodeship, Poland, 71-434
Actively Recruiting
81
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
Lodz, Poland, 91-738
Actively Recruiting
82
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland, 93-338
Actively Recruiting
83
Narodny ustav detskych chorob
Bratislava, Slovakia, 833 40
Withdrawn
84
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, South Korea, 41404
Actively Recruiting
85
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea, 21565
Terminated
86
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
87
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
88
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Withdrawn
89
Hospital Sant Joan de Deu - PIN
Barcelona, Spain, 8950
Withdrawn
90
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, Spain, 28009
Withdrawn
91
Hospital Regional Universitario de Malaga Hospital Materno-Infantil
Málaga, Spain, 29011
Withdrawn
92
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Withdrawn
93
Great Ormond Street Hospital
London, London, City of, United Kingdom, WC1N 3AJ
Withdrawn
94
Noahs Ark Childrens Hospital for Wales - PIN
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Withdrawn
95
King's College Hospital
London, Surrey, United Kingdom, SE5 9RS
Withdrawn
96
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, Warwickshire, United Kingdom, B4 6NH
Actively Recruiting
97
Barts Health NHS Trust - PPDS
London, United Kingdom, E1 1BB
Not Yet Recruiting
98
Royal Manchester Children's Hospital - PPDS - PIN
Manchester, United Kingdom, M27 4HA
Withdrawn
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
7
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