A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
NCT ID: NCT04779320
Last Updated: 2025-10-20
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
120 participants
INTERVENTIONAL
2022-02-10
2026-05-22
Brief Summary
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The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
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Detailed Description
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The study will enroll approximately 120 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 10 to 15 kg, Vedolizumab 150 mg
* Participants \>15 to \<30 kg, Vedolizumab 200 mg
* Participants ≥30 kg, Vedolizumab 300 mg
At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and by weight groups. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows:
* Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose)
* Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) 100 mg (Low dose)
* Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose)
The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion to the high dose in their weight group based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance Period.
This multi-center trial will be conducted worldwide. After the Week 54, participants may be eligible to continue receiving vedolizumab in extension study MLN0002-3029. Participants who do not maintain corticosteroid-free clinical response at week 54 will undergo an end-of-study (EOS) or ET visit, and a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks), in addition these participants will then be eligible to enter study MLN0002-3029 for an observational LTFU period of 2 years after the last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Induction Period: 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Vedolizumab IV
Vedolizumab IV
Induction Period: >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of \>15 to \<30 kg will be included in this arm group.
Vedolizumab IV
Vedolizumab IV
Induction Period: ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Vedolizumab IV
Vedolizumab IV
Maintenance Period: ≥30 kg: Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Vedolizumab IV
Vedolizumab IV
Interventions
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Vedolizumab IV
Vedolizumab IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.
3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \>30 and an 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.
4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
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 with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug.
4. The participants has received any live vaccinations within 30 days prior to first dose.
5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
6. 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.
7. Participants with a current diagnosis of indeterminate colitis.
8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:
* Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
* A TB skin test reaction ≥5 mm.
10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \[HBsAg\]-negative and hepatitis B antibody-positive) may, however, be included.
Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA).
Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]).
12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
15. 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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Locations
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Phoenix Childrens Hospital
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
I.H.S Health LLC
Kissimmee, Florida, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MNGI Digestive Health, PA
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, United States
University of Rochester Medical Center PPDS
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Texas Children's Hospital
Houston, Texas, United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
UZ Antwerpen
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Beijing Children Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Henan Children's Hospital(Zhengzhou Children's Hospital)
Zhengzhou, Henan, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, China
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, Croatia
University Hospital Center Zagreb
Zagreb, City of Zagreb, Croatia
University Hospital Centre Split
Split, , Croatia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, Czechia
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Attikon University General Hospital
Athens, Attica, Greece
Children's Hospital "Agia Sofia"
Athens, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Central District, Israel
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, Jerusalem, Israel
Soroka University Medical Centre
Beersheba, , Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center - PPDS
Jerusalem, , Israel
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy
Sapienza University of Rome
Rome, Lazio, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy, Italy
Universita degli Studi di Padova
Padua, Veneto, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, Lithuania
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, , Slovakia
Narodny ustav detskych chorob
Bratislava, , Slovakia
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University Hospital
Seongnam, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Málaga, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Kings College Hospital
London, London, City of, United Kingdom
Great Ormond Street Hospital (GOSH)
London, London, City of, United Kingdom
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Manchester Children's Hospital - PPDS
Manchester, , United Kingdom
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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2020-004301-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2071210031
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509045-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
MLN0002-3025
Identifier Type: -
Identifier Source: org_study_id
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