Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
6 other identifiers
interventional
89
11 countries
88
Brief Summary
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2017
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2020
CompletedResults Posted
Study results publicly available
December 21, 2020
CompletedDecember 21, 2020
November 1, 2020
2.4 years
April 19, 2017
November 25, 2020
November 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14
From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14
From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14
At the end of a dosing interval at Week 14
Secondary Outcomes (2)
Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score
Baseline (Day 1) and Week 14
Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)
Baseline (Day 1) and Week 14
Study Arms (8)
UC: <30 kg Participants, Vedolizumab 100 mg
EXPERIMENTALParticipants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
UC: <30 kg Participants, Vedolizumab 200 mg
EXPERIMENTALParticipants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
CD: <30 kg Participants, Vedolizumab 100 mg
EXPERIMENTALParticipants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
CD: <30 kg Participants, Vedolizumab 200 mg
EXPERIMENTALParticipants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
UC: >=30 kg Participants, Vedolizumab 150 mg
EXPERIMENTALParticipants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
UC: >=30 kg Participants, Vedolizumab 300 mg
EXPERIMENTALParticipants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
CD: >=30 kg Participants, Vedolizumab 150 mg
EXPERIMENTALParticipants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
CD: >=30 kg Participants, Vedolizumab 300 mg
EXPERIMENTALParticipants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Interventions
Vedolizumab IV infusion.
Eligibility Criteria
You may qualify if:
- Participants weighs \>=10 kg at the time of randomization.
- Has a medical history of moderately to severely active UC during Screening defined as complete Mayo score of 6 to 12, and a total Mayo subscores of stool frequency and rectal bleeding \>=4 and Mayo endoscopy subscore \>=2, or has moderately to severely active CD defined as simple endoscopic score for Crohn's disease (SES-CD) \>=7, and the CDAI components of average daily abdominal pain score of greater than (\>) 1 for the 7 days prior, and total number of liquid/very soft stools \>10 within 7 days prior to first dose of study drug.
- Has evidence of UC extending proximal to the rectum (that is, not limited to proctitis) or evidence of CD involving the ileum and/or colon, at a minimum.
- Has extensive colitis or pancolitis of \>8 years duration or left-sided colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to their first dose of study drug.
- Has a family history of colorectal cancer (that is, first-degree relative), personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
- The participant's vaccinations are up to date.
- Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
- Corticosteroids:
- Signs and/or symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to or more than prednisone 1 milligram per kilogram (mg/kg) daily orally for 2 weeks or IV for 1 week.
- Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on 2 separate occasions.
- History of significant intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
- Immunomodulators:
- Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (AZA) (\>=1.5 milligram per kilogram per day \[mg/kg/day\]) or 6-mercaptopurine (6-MP) mg/kg (\>=1.0 mg/kg/day) or methotrexate (MTX) (\>=10 milligram per square meter \[mg/m\^2\] once a week).
- History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test (LFT) abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, infection).
- Tumor necrosis factor-alpha (TNF-α) antagonists:
- +11 more criteria
You may not qualify if:
- Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, or AMG 181) or MAdCAM-1 antagonists, or rituximab.
- Has had prior exposure to vedolizumab.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
- Requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for UC or CD during this study.
- Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug.
- Has any unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
- 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 millimeter (mm). Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
- Clinically significant current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
- Has a current diagnosis of indeterminate colitis (Inflammatory bowel disease unclassified \[IBDU\]). For participants less than 6 years of age, any findings that suggest monogenic very early onset inflammatory bowel disease should be excluded.
- Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
- Has ileostomy, colostomy, ileo-anal pouch, or known fixed symptomatic stenosis of the intestine.
- Has extensive colonic resection, example, subtotal or total colectomy.
- Has a history or evidence of adenomatous colonic polyps that have not been removed.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (88)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California San Francisco
San Francisco, California, 94143-0135, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106-3322, United States
Nemours Children's Clinic
Wilmington, Delaware, 19803, United States
Nemours Childrens Specialty Care - Jacksonville
Jacksonville, Florida, 32207, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905-0001, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Northwell Health
Lake Success, New York, 11042, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10031, United States
The Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Childrens Medical Center of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Children's Specialty Group - Medical Center Location
Norfolk, Virginia, 23507, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hopital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, 1020, Belgium
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, 3000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
University of Alberta
Edmonton, Alberta, T6G 1C9, Canada
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4, Canada
Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3A 1S1, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5, Canada
London Health Sciences Centre University Hospital
London, Ontario, N6A 5W9, Canada
Toronto Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, H4A 3J1, Canada
Hopital Jeanne de Flandre
Lille, Hauts-de-France, 59037, France
Hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
Hopital Necker-Enfants Malades
Paris, Île-de-France Region, 75015, France
Hopital Robert Debre
Paris, Île-de-France Region, 75935, France
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075, Germany
Ludwig-Maximillians-Universitat Munchen
München, Bavaria, 80337, Germany
Universitatsmedizin Rostock - Kinder und Jugendklinik
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitatsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, 04103, Germany
BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720, Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
Sopron, Győr-Moson-Sopron, 9400, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Soroka University Medical Center
Beersheba, Beersheba, 8410101, Israel
Schneider Children's Medical Center of Israel
Petach Tikvah, Petah Tiqwa, 4920235, Israel
Assaf Harofeh Medical Center
Ẕerifin, Rehoboth, 7030000, Israel
The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
Ramat Gan, Tel Aviv, 52621, Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Radboud Universitair Medisch Centrum
Nijmegen, GA, 6525, Netherlands
Emma Kinderziekenhuis AMC
Amsterdam, North Holland, 1105AZ, Netherlands
Isala Klinieken
Zwolle, Overijssel, 8025 AB, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GJ, Netherlands
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, 30-663, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-369, Poland
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, 01-184, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-274, Poland
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship, 80-803, Poland
Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE
Szczecin, West Pomeranian Voivodeship, 70-780, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
Lodz, Łódź Voivodeship, 91-738, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338, Poland
National Scientific Center of Radiological Medicine of NAMS of Ukraine
Kyiv, KIEV CITY, 03115, Ukraine
Kharkiv Regional Clinical Children's Hospital
Kharkiv, 61093, Ukraine
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, England, B4 6NH, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 0QQ, United Kingdom
Barts and The London NHS Trust
London, England, E1 1BB, United Kingdom
King's College Hospital
London, England, SE5 9RS, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, WC1N 3JH, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, England, M13 9WL, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, England, OX3 9DU, United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, England, S10 2TH, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, G51 4TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Monitor Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
May 3, 2017
Study Start
November 8, 2017
Primary Completion
March 31, 2020
Study Completion
May 26, 2020
Last Updated
December 21, 2020
Results First Posted
December 21, 2020
Record last verified: 2020-11
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.