Actively Recruiting
A Study to Evaluate Vedolizumab Intravenous as Maintenance Therapy in Children and Teenagers With Moderate to Severe Crohn's Disease After Initial Vedolizumab Treatment
Led by Takeda · Updated on 2026-05-05
120
Participants Needed
96
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying vedolizumab, a medicine designed to reduce inflammation and pain in the digestive system, for children and teenagers with moderate to severe Crohn's disease who have not responded well or were intolerant to standard treatments. The main goal is to see if participants can achieve remission, meaning their symptoms improve or disappear and endoscopy shows no inflammation. This phase 3, randomized, double-blind study involves about 120 pediatric participants worldwide. Participants will receive three intravenous infusions of vedolizumab over six weeks during the Induction Period, with doses based on their weight. Those who show a clinical response at Week 14 will be randomly assigned to receive either a high or low dose of vedolizumab every eight weeks up to Week 46 during the Maintenance Period. Dose adjustments may be made if disease worsens, and corticosteroid rescue therapy is allowed once during maintenance. After Week 54, eligible participants may continue treatment in an extension study or enter long-term follow-up. Throughout the study, participants will undergo assessments including clinical evaluations, endoscopies, and laboratory tests to measure disease activity and remission using tools like the Pediatric Crohn's Disease Activity Index and Simple Endoscopic Score for Crohn's Disease. Safety will be monitored through reports of adverse events and antibody levels against vedolizumab. The total participation can include additional safety visits and up to two years of long-term follow-up after the last dose.
CONDITIONS
Brief Title
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and teenagers aged 2 to 17 years
- Diagnosed with moderate to severe Crohn's disease at least 1 month before screening
- Pediatric Crohn's Disease Activity Index (PCDAI) score greater than 30
- Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than 6, or greater than or equal to 4 if disease is limited to terminal ileum
- Weigh at least 10 kilograms at screening and enrollment
- Have failed, lost response to, or been intolerant to at least one standard treatment including corticosteroids, immunomodulators, or TNF-alpha antagonists
- Up-to-date with vaccinations according to local childhood vaccine schedules
- For those with extensive colitis or pancolitis over 8 years, or left-sided colitis over 12 years, must have had a negative colonoscopy within 12 months before screening
You will not qualify if you...
- Received investigational biologics (other than allowed) within 60 days or 5 half-lives before screening
- Received approved biologics or biosimilars within 2 weeks before first study dose or during screening
- History or signs of major neurological disorders including progressive multifocal leukoencephalopathy, stroke, multiple sclerosis, brain tumor, or neurodegenerative disease
- Had significant infection within 30 days before first study dose
- Received any live vaccinations within 30 days before first study dose
- Require or anticipate need for surgical intervention for Crohn's disease during the study
- History of subtotal or total colectomy or certain intestinal surgeries or conditions
- Diagnosis of indeterminate colitis
- Features suggesting monogenic very early-onset inflammatory bowel disease
- Active or latent tuberculosis as evidenced by recent diagnostic tests
- Positive hepatitis B surface antigen or core antibody unless confirmed absence of HBV DNA
- Chronic hepatitis C infection
- Identified congenital or acquired immunodeficiency including HIV or organ transplant
- Evidence of dysplasia or history of malignancy except certain treated skin or cervical cancers
- Positive stool tests for parasites or Clostridioides difficile infection at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive vedolizumab intravenous (IV) infusions based on their weight at Baseline. This includes 3 doses given at Day 1, Week 2, and Week 6.
3 infusion visits (in-person)
Duration - Week 14 to Week 46
Participants who achieve clinical response at Week 14 are randomly assigned to receive vedolizumab IV infusions every 8 weeks until Week 46. Dose depends on weight and assigned group (high or low dose). Dose escalation may occur if clinical response is lost. One-time rescue corticosteroid therapy is allowed if needed.
5 infusion visits (in-person) approximately every 8 weeks
Duration - Up to 2 years after last dose
Participants who do not maintain corticosteroid-free clinical response at Week 54 will have an end-of-study or early termination visit, followed by a safety visit 18 weeks after the last dose of vedolizumab. These participants may enter a long-term follow-up observational period lasting up to 2 years.
Visits at end-of-study, safety visit 18 weeks later, and additional visits during long-term follow-up
Trial Site Locations
Total: 96 locations
1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Withdrawn
3
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States, 92123
Not Yet Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94143
Withdrawn
5
I.H.S Health LLC
Kissimmee, Florida, United States, 34741
Withdrawn
6
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
8
Riley Hospital For Children
Indianapolis, Indiana, United States, 46202
Withdrawn
9
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
10
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
11
MNGI Digestive Health, PA
Minneapolis, Minnesota, United States, 55413
Actively Recruiting
12
Mayo Clinic - PIN
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
13
Goryeb Children's Hospital
Morristown, New Jersey, United States, 07960
Actively Recruiting
14
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, United States, 11042
Actively Recruiting
15
University of Rochester Medical Center PPDS
Rochester, New York, United States, 14642
Withdrawn
16
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
17
SUNY Upstate Medical Center
Syracuse, New York, United States, 13202
Withdrawn
18
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
19
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15201
Not Yet Recruiting
20
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Withdrawn
21
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively 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
Not Yet 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
Not Yet Recruiting
27
UZ Antwerpen
Edegem, Antwerpen, Belgium, 2650
Not Yet Recruiting
28
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, Belgium, 1090
Not Yet Recruiting
29
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Not Yet Recruiting
30
University of Alberta Hospital
Edmonton, Alberta, Canada, AB T6G 2B7
Not Yet Recruiting
31
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H3V4
Not Yet Recruiting
32
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Not Yet Recruiting
33
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Not Yet Recruiting
34
Beijing Children Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100045
Not Yet Recruiting
35
Henan Children's Hospital(Zhengzhou Children's Hospital)
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
36
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Not Yet Recruiting
37
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
38
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
39
University Hospital Center Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
40
University Hospital Centre Split
Split, Croatia, 21000
Actively Recruiting
41
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, Czechia, 100 34
Not Yet Recruiting
42
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, Czechia, 140 00
Not Yet Recruiting
43
Fakultni nemocnice Ostrava
Ostrava, Czechia
Not Yet Recruiting
44
Attikon University General Hospital
Athens, Attica, Greece, 124 62
Actively Recruiting
45
Children's Hospital "Agia Sofia"
Athens, Greece
Actively Recruiting
46
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Not Yet Recruiting
47
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Actively Recruiting
48
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
Actively Recruiting
49
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, Hungary, 6720
Actively Recruiting
50
Semmelweis Egyetem
Budapest, Hungary, 1083
Not Yet Recruiting
51
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Central District, Israel, 49202
Not Yet Recruiting
52
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, Jerusalem, Israel, 90000
Not Yet Recruiting
53
Soroka University Medical Centre
Beersheba, Israel, 84101
Not Yet Recruiting
54
Rambam Medical Center - PPDS
Haifa, Israel, 31096
Not Yet Recruiting
55
Carmel Medical Center
Haifa, Israel, 34362
Not Yet Recruiting
56
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Not Yet Recruiting
57
Hadassah Medical Center - PPDS
Jerusalem, Israel, 91120
Not Yet Recruiting
58
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80131
Not Yet Recruiting
59
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy, 80131
Not Yet Recruiting
60
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy, 40133
Not Yet Recruiting
61
Sapienza University of Rome
Rome, Lazio, Italy, 161
Actively Recruiting
62
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy, Italy, 20900
Not Yet Recruiting
63
Universita degli Studi di Padova
Padova, Veneto, Italy, 35122
Not Yet Recruiting
64
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan, 830-0011
Actively Recruiting
65
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan, 861-8520
Actively Recruiting
66
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8431
Actively Recruiting
67
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan, 157-8535
Actively Recruiting
68
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, Lithuania, LT-50161
Withdrawn
69
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, Lithuania, 8406
Withdrawn
70
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland, 30-663
Not Yet Recruiting
71
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
Not Yet Recruiting
72
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland, 00-728
Not Yet Recruiting
73
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland, 04-736
Actively Recruiting
74
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
Actively Recruiting
75
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Not Yet Recruiting
76
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, Poland, 40-752
Not Yet Recruiting
77
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland, 71-434
Actively Recruiting
78
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, Poland, 91-738
Not Yet Recruiting
79
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland, 93-338
Not Yet Recruiting
80
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, Slovakia, 974 09
Terminated
81
Narodny ustav detskych chorob
Bratislava, Slovakia, 833 40
Terminated
82
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, South Korea, 41404
Actively Recruiting
83
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea, 21565
Actively Recruiting
84
Seoul National University Hospital
Seongnam, South Korea, Seoul
Actively Recruiting
85
Samsung Medical Center - PPDS
Seoul, South Korea, 6351
Actively Recruiting
86
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, Spain, 8950
Withdrawn
87
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Withdrawn
88
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, Spain, 28009
Withdrawn
89
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Málaga, Spain, 29011
Withdrawn
90
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Withdrawn
91
Kings College Hospital
London, London, City of, United Kingdom, SE5 9RS
Not Yet Recruiting
92
Great Ormond Street Hospital (GOSH)
London, London, City of, United Kingdom, WC1N 3AJ
Not Yet Recruiting
93
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Not Yet Recruiting
94
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B4 6NH
Not Yet Recruiting
95
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Not Yet Recruiting
96
Royal Manchester Children's Hospital - PPDS
Manchester, United Kingdom, M27 4HA
Not Yet Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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