Last updated on June 2018

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)


Brief description of study

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.

Detailed Study Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD. This study will look at the PK, efficacy, immunogenicity, safety, and tolerability in participants who take vedolizumab.

The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight group >=30 kg and 10 kg to <30 kg in ratio 1:1which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab high dose group - Vedolizumab 300 mg or 200 mg
  • Vedolizumab low dose group - Vedolizumab 150 mg or 100 mg

All participants will be administered vedolizumab via IV infusion. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric UC/CDAI) at Week 14 will receive the high dose (that is, 300 mg for participants >=30 kg baseline weight and 200 mg for participants 10 kg to <30 kg baseline weight) of vedolizumab IV at Week 14.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 36 weeks. After completing the Week 22 Visit procedures, eligible participants may enter an extension study. Participants will make multiple visits to the clinic, and those who do not enter extension study will have a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants who do not enter the extension study will also participate in a long-term safety follow-up, by telephone, 6 months after the last dose of study drug.

Clinical Study Identifier: NCT03138655

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Cedars-Sinai Medical Center
Los Angeles, CA United States
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University of California San Francisco
San Francisco, CA United States
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Connecticut Children's Medical Center
Hartford, CT United States
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Nemours Childrens Specialty Care - Jacksonville
Jacksonville, FL United States
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Children's Center for Digestive Healthcare
Atlanta, GA United States
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Massachusetts General Hospital
Boston, MA United States
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Boston Children's Hospital
Boston, MA United States
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Mount Sinai Medical Center
New York, NY United States
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The Children's Hospital of Philadelphia
Philadelphia, PA United States
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Medical University of South Carolina
Charleston, SC United States
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Childrens Medical Center of Dallas
Dallas, TX United States
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Texas Children's Hospital
Houston, TX United States
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University of Utah
Salt Lake City, UT United States
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Children's Specialty Group - Medical Center Location
Norfolk, VA United States
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Seattle Children's Hospital
Seattle, WA United States
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Universitair Ziekenhuis Brussel
Brussel, Belgium
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Hopital Universitaire des Enfants Reine Fabiola
Bruxelles, Belgium
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Universitair Ziekenhuis Leuven
Leuven, Belgium
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Cliniques Universitaires Saint-Luc
Brussels, Belgium
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University of Calgary
Calgary, AB Canada
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University of Alberta Hospital
Edmonton, AB Canada
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Children's and Women's Health Centre of British Columbia
Vancouver, BC Canada
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Children's Hospital of Winnipeg
Winnipeg, MB Canada
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IWK Health Centre
Halifax, NS Canada
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McMaster Children's Hospital
Hamilton, ON Canada
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London Health Sciences Centre University Hospital
London, ON Canada
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Toronto Hospital for Sick Children
Toronto, ON Canada
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Centre Hospitalier Universitaire Sainte-Justine
Montreal, QC Canada
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McGill University Health Centre Glen Site
Montreal, QC Canada
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Hopital Necker-Enfants Malades
Paris Cedex 15, France
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Hopital Robert Debre
Paris Cedex 19, France
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Hopital de la Timone
Marseille Cedex 5, France
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Hopital Jeanne de Flandre
Lille Cedex, France
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Universitatsklinikum Ulm
Ulm, Germany
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Ludwig-Maximillians-Universitat Munchen
Munchen, Germany
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Universitatsmedizin Rostock - Kinder und Jugendklinik
Rostock, Germany
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Universitatsklinikum Aachen
Aachen, Germany
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Universitaetsklinikum Leipzig AoeR
Leipzig, Germany
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BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
Miskolc, Hungary
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Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
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Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
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Semmelweis Egyetem
Budapest, Hungary
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Soroka University Medical Center
Beer-sheva, Israel
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Schneider Children's Medical Center of Israel
Petach Tikvah, Israel
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The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
Ramat Gan, Israel
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Rambam Health Care Campus - Rambam Medical Center
Haifa, Israel
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Shaare Zedek Medical Center
Jerusalem, Israel
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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
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Assaf Harofeh Medical Center
Zerifin, Israel
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Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
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Emma Kinderziekenhuis AMC
Amsterdam, Netherlands
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Isala Klinieken
Zwolle, Netherlands
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Erasmus University Medical Center
Rotterdam, Netherlands
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Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland
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Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszow, Poland
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Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku
Bialystok, Poland
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Copernicus Podmiot Leczniczy
Gdansk, Poland
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National Scientific Center of Radiological Medicine of NAMS of Ukraine
Kyiv, Ukraine
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Kharkiv Regional Clinical Children's Hospital
Kharkiv, Ukraine
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
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NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
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Barts and The London NHS Trust
London, United Kingdom
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King's College Hospital
London, United Kingdom
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Children's Hospital of Orange County
Orange, CA United States
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Nemours Children's Clinic
Wilmington, DE United States
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Nicklaus Children's Hospital
Miami, FL United States
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, IL United States
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Indiana University School of Medicine - Indianapolis
Indianapolis, IN United States
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Mayo Clinic - Rochester
Rochester, MN United States
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Washington University in St. Louis
Saint Louis, MO United States
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Northwell Health
Lake Success, NY United States
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New York, NY United States
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Children's Hospital of Pittsburgh
Pittsburgh, PA United States
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Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
Sopron, Hungary
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Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE
Szczecin, Poland
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Bronx, NY United States
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University Hospitals Rainbow Babies & Children's Hospital
Cleveland, OH United States
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Carmel Medical Center
Haifa, Israel
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
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Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
Lodz, Poland
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Instytut Centrum Zdrowia Matki Polki
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Birmingham, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Oxford, United Kingdom
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Sheffield, United Kingdom
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