A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
4 other identifiers
interventional
120
18 countries
96
Brief Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2022
Longer than P75 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 13, 2027
May 5, 2026
April 1, 2026
5.6 years
March 1, 2021
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of \<10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and \>30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
Week 54
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.
Week 54
Secondary Outcomes (19)
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Week 14
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Week 54
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Week 54
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Week 54
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Week 14
- +14 more secondary outcomes
Study Arms (9)
Induction Period: 10 to 15 kg, Vedolizumab 150 mg
EXPERIMENTALVedolizumab 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.
Induction Period: >15 to <30 kg, Vedolizumab 200 mg
EXPERIMENTALVedolizumab 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.
Induction Period: ≥30 kg, Vedolizumab 300 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: ≥30 kg, Vedolizumab 300 mg
EXPERIMENTALVedolizumab 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.
Maintenance Period: ≥30 kg: Vedolizumab 150 mg
EXPERIMENTALVedolizumab 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.
Interventions
Vedolizumab IV
Eligibility Criteria
You may qualify if:
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- 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.
- 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.
- 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.
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
You may not qualify if:
- 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.
- 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.
- The participants has received any live vaccinations within 30 days prior to first dose.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
- 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.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
- 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.
- 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.
- 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 \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]).
- The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (96)
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94143, United States
I.H.S Health LLC
Kissimmee, Florida, 34741, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, 30342, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, 60068, United States
Riley Hospital For Children
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MNGI Digestive Health, PA
Minneapolis, Minnesota, 55413, United States
Mayo Clinic - PIN
Rochester, Minnesota, 55905, United States
Goryeb Children's Hospital
Morristown, New Jersey, 07960, United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, 11042, United States
University of Rochester Medical Center PPDS
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
SUNY Upstate Medical Center
Syracuse, New York, 13202, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15201, United States
Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, 24018, United States
Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, 4101, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, 3052, Australia
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, 1090, Belgium
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H3V4, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Beijing Children Hospital,Capital Medical University
Beijing, Beijing Municipality, 100045, China
Henan Children's Hospital(Zhengzhou Children's Hospital)
Zhengzhou, Henan, 450000, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, 310003, China
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000, Croatia
University Hospital Centre Split
Split, 21000, Croatia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, 100 34, Czechia
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, 140 00, Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia
Attikon University General Hospital
Athens, Attica, 124 62, Greece
Children's Hospital "Agia Sofia"
Athens, Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 564 29, Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 564 29, Greece
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Central District, 49202, Israel
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, Jerusalem, 90000, Israel
Soroka University Medical Centre
Beersheba, 84101, Israel
Rambam Medical Center - PPDS
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center - PPDS
Jerusalem, 91120, Israel
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131, Italy
Azienda USL di Bologna
Bologna, Emilia-Romagna, 40133, Italy
Sapienza University of Rome
Rome, Lazio, 161, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Lombardy, 20900, Italy
Universita degli Studi di Padova
Padova, Veneto, 35122, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431, Japan
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, LT-50161, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, 8406, Lithuania
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, 30-663, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-369, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, 00-728, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, 04-736, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-803, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, 40-752, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 91-738, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338, Poland
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, 974 09, Slovakia
Narodny ustav detskych chorob
Bratislava, 833 40, Slovakia
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, 41404, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, 21565, South Korea
Seoul National University Hospital
Seongnam, Seoul, South Korea
Samsung Medical Center - PPDS
Seoul, 6351, South Korea
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, 8950, Spain
Hospital de Sagunto
Sagunto, Valencia, 46520, Spain
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, 28009, Spain
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Málaga, 29011, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Kings College Hospital
London, London, City of, SE5 9RS, United Kingdom
Great Ormond Street Hospital (GOSH)
London, London, City of, WC1N 3AJ, United Kingdom
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, West Midlands, B4 6NH, United Kingdom
Barts Health NHS Trust
London, E1 1BB, United Kingdom
Royal Manchester Children's Hospital - PPDS
Manchester, M27 4HA, United Kingdom
Related Links
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 3, 2021
Study Start
February 10, 2022
Primary Completion (Estimated)
September 13, 2027
Study Completion (Estimated)
September 13, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.