A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

PHASE3CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

March 17, 2021

Primary Completion Date

May 8, 2025

Study Completion Date

June 5, 2025

Conditions
Colitis, Ulcerative
Interventions
DRUG

Ustekinumab Dose Based on BSA and Body Weight

As per BSA and body weight Ustekinumab will be administered SC and IV.

DRUG

Matching Placebo

Placebo will be administered subcutaneously.

Trial Locations (58)

1020

Universitair Kinderziekenhuis Koningin Fabiola, Brussels

1083

Semmelweis Egyetem, Budapest

1090

UZ Brussel, Jette

1200

Cliniques Universitaires Saint Luc, Brussels

3000

UZ Leuven, Leuven

3526

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz, Miskolc

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4400

Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz, Nyíregyháza

6720

Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum, Szeged

9000

UZ Gent, Ghent

13353

Charite-Universitätsmedizin Berlin - Berlin, Berlin

17033

Penn State Hershey Children's Hospital, Hershey

19803

Nemours DuPont Hospital for Children, Wilmington

22031

Pediatric Specialists Of Virginia, Fairfax

28207

Levine Childrens at Atrium Health, Charlotte

30342

Children's Center for Digestive Health Care, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

30700

Sheba Medical Center, Ramat Gan

44106

University Hospitals Cleveland Medical Center, Cleveland

45147

Universitatsklinikum Essen, Essen

52074

Universitätsklinikum Aachen, Aachen

55905

Mayo Clinic, Rochester

70300

Shamir Medical Center Assaf Harofeh, Be’er Ya‘aqov

76104

Cook Childrens Medical Center, Fort Worth

80337

Dr. von Haunersches Kinderspital, Munich

89075

Universitatsklinikum Ulm, Ulm

91054

Universitatsklinikum Erlangen, Erlangen

93049

KUNO Klinik St. Hedwig, Regensburg

119571

Russian National Research Medical University named after N.I.Pirogov, Moscow

119991

FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences, Moscow

150032

Yaroslavl Regional Children's Clinical Hospital, Yaroslavl

410054

Saratov State Medical University, Saratov

420138

Kazan State Medical University, Kazan'

603950

Privolzhsky Research Medical University of Ministry of Health of Russian Federation, Nizhny Novgorod

3109601

Rambam Medical Center, Haifa

3436212

Carmel Medical Center, Haifa

4920235

Schneider Children's Medical Center, Petah Tikva

9103102

Shaare Zedek Medical Center, Jerusalem

07962

Morristown Memorial Hospital, Morristown

113 8431

Juntendo University Hospital, Bunkyō City

371-0034

Gunma University Hospital, Gunma

630-0293

Kindai University Nara Hospital, Ikoma

830-0011

Kurume University Hospital, Kurume

330-8777

Saitama Childrens Medical Center, Saitama Shi

989-3126

Miyagi Children's Hospital, Sendai

157 8535

National Center for Child Health and Development, Setagaya Ku

329-0498

Jichi Medical University Hospital, Shimotsuke

514 8507

Mie University Hospital, Tsu

80 803

Szpital im. M. Kopernika, Gdansk

30 663

Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow

35-302

Korczowski Bartosz Gabinet Lekarski, Rzeszów

87 100

GASTROMED Sp. z o.o., Torun

04 501

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

04 730

Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw

B4 6NH

Birmingham Children's Hospital, Birmingham

BS2 8BJ

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

E1 2AT

Royal London Hospital, London

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04630028 - A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) | Biotech Hunter | Biotech Hunter