Last updated on September 2017

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis or Crohn's Disease


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 ulcerative colitis or Crohn's disease.

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 ulcerative colitis (UC) or Crohn's disease (CD). This study will look at the pharmacokinetics (PK), efficacy, immunogenicity, safety, and tolerability in participants who take vedolizumab. The study will enroll approximately 80 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight group in ratio 1:1—which 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 intravenous (IV) infusion. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric ulcerative colitis/Crohn's disease activity index) at Week 14 will receive the high dose (ie, 300 mg for participants ≥30 kg baseline weight and 200 mg for participants <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
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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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Northwestern University Feinberg School of Medicine
Chicago, IL United States
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Massachusetts General Hospital
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Boston Children's Hospital
Boston, MA United States
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Mayo Clinic
Rochester, MN United States
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Northwell Health
New Hyde Park, NY 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
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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, 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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Leuven, Belgium
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Cliniques Universitaires Saint-Luc
Brussels, Belgium
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Calgary, AB Canada
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Edmonton, AB Canada
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Vancouver, BC Canada
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Halifax, NS Canada
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Hamilton, ON Canada
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London, ON Canada
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Toronto, ON Canada
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Montreal, QC Canada
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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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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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Aachen, Germany
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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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Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
Szekszard, Hungary
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Semmelweis Egyetem
Budapest, Hungary
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Beer-sheva, Israel
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Petach Tikvah, Israel
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Ramat Gan, Israel
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Haifa, Israel
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Jerusalem, Israel
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Zerifin, Israel
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Nijmegen, Netherlands
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Amsterdam, Netherlands
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Isala Klinieken
Zwolle, Netherlands
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Rotterdam, Netherlands
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Wroclaw, 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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Szczecin, 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, Ukraine
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Cambridge, United Kingdom
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