A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 18, 2017

Primary Completion Date

September 19, 2018

Study Completion Date

March 18, 2022

Conditions
Crohn Disease
Interventions
DRUG

Ustekinumab

Subjects will receive a single IV administration of ustekinumab (3 mg/kg for subjects \<40 kg or 130 mg for subjects \>= 40 kg in Group 1 and 9 mg/kg for subjects \< 40 kg or 390 mg for subjects \>= 40 kg in group 2) at week 0 followed by SC administration of ustekinumab (2 mg/kg for subjects \< 40 kg or 90 mg for subjects \>= 40 kg at Week 8.

Trial Locations (26)

1020

Universitair Kinderziekenhuis Koningin Fabiola, Brussels

1090

UZ Brussel, Jette

1200

Cliniques Universitaires Saint Luc, Brussels

3000

UZ Leuven, Leuven

9000

UZ Gent, Ghent

10029

Mount Sinai, New York

19104

Childrens Hospital Of Philadelphia, Philadelphia

29615

Center For Digestive Health Systems-Greenville, Greenville

30322

Emory University, Atlanta

30342

Children's Center For Digestive Healthcare, Llc, Atlanta

42283

HELIOS Klinikum Wuppertal GmbH, Wuppertal

55905

Mayo Clinic, Rochester

61602

Methodist Medical Center of Illinois, Peoria

75015

Hôpital Necker, Paris

75019

Hôpital Robert Debré, Paris

80337

Dr. von Haunersches Kinderspital, Munich

90048

Cedars Sinai Medical Center, Los Angeles

06106

Connecticut Childrens Medical Center, Hartford

T6G 2B7

Stollery Children's Hospital, Edmonton

V6H3V4

British Columbia Children's Hospital, Vancouver

N6A 5W9

Children's Hospital of Western Ontario, London

M5G 1X8

Hospital For Sick Children, Toronto

H3T 1C5

Centre Hospitalier Sainte Justine, Montreal

93 338

Instytut Centrum Zdrowia Matki Polki, Lodz

00-728

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

50 369

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02968108 - A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease | Biotech Hunter | Biotech Hunter