A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• Must have completed the dosing planned in the primary pediatric ustekinumab study

• Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)

• Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

• Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

• Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Locations
United States
Georgia
Children's Center For Digestive Healthcare, Llc
ACTIVE_NOT_RECRUITING
Atlanta
North Carolina
Levine Childrens at Atrium Health
ACTIVE_NOT_RECRUITING
Charlotte
New York
Mount Sinai
COMPLETED
New York
Virginia
Pediatric Specialists Of Virginia
ACTIVE_NOT_RECRUITING
Fairfax
Other Locations
Argentina
STAT Research S A
RECRUITING
Buenos Aires
Hospital de Ninos de Cordoba
RECRUITING
Córdoba
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Belgium
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Huderf
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
UZ Brussel
RECRUITING
Jette
Uz Gasthuisberg
RECRUITING
Leuven
France
Hôpital Necker
COMPLETED
Paris
Germany
Universitaetsklinikum der RWTH Aachen
COMPLETED
Aachen
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
RECRUITING
Berlin
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
RECRUITING
Miskolc
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
RECRUITING
Nyíregyháza
Szegedi Tudomanyegyetem
COMPLETED
Szeged
Israel
Yitzhak Shamir Medical Center
ACTIVE_NOT_RECRUITING
Beer Yaakov
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
RECRUITING
Milan
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Gunma University Hospital
RECRUITING
Gunma
Kindai University Nara Hospital
RECRUITING
Ikoma
Kurume University Hospital
RECRUITING
Kurume
Saitama Childrens Medical Center
RECRUITING
Saitama Shi
Miyagi Children's Hospital
RECRUITING
Sendai
National Center for Child Health and Development
RECRUITING
Setagaya Ku
Mie University Hospital
RECRUITING
Tsu
Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
RECRUITING
Krakow
Korczowski Bartosz Gabinet Lekarski
RECRUITING
Rzeszów
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
RECRUITING
Sosnowiec
GASTROMED Sp. z o.o.
RECRUITING
Torun
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Medical Network
RECRUITING
Warsaw
Spain
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Turkey
Hacettepe University Medical Faculty
RECRUITING
Ankara
Cerrahpasa Medical Faculty Hospital
RECRUITING
Istanbul
United Kingdom
Birmingham Children's Hospital
RECRUITING
Birmingham
Addenbrookes Hospital
RECRUITING
Cambridge
Great Ormond Street Hospital
RECRUITING
London
Royal London Hospital
RECRUITING
London
Sheffield Children's Hospital
RECRUITING
Sheffield
Southampton University Hospital
RECRUITING
Southampton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2021-10-18
Estimated Completion Date: 2027-09-29
Participants
Target number of participants: 151
Treatments
Experimental: Ustekinumab
Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov