Back to Trials
NCT06663332PHASE3Recruiting

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Janssen Research & Development, LLC

Start Date

10/29/2024

Completion Date

2/25/2032

Summary

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Eligibility Criteria

Age Range: 3 years to No maximum

Inclusion Criteria: * Must have completed the dosing planned in the primary pediatric guselkumab study * Must have received benefit from continued guselkumab therapy in the opinion of the investigator * Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure * Parent(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 required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate. Exclusion Criteria: * Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication * Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication * Are pregnant, nursing, or planning pregnancy or fathering a child * Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention * Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Interventions

DRUG

Guselkumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Crohns DiseaseColitis, UlcerativeArthritis, PsoriaticArthritis, Juvenile

Locations

Emory University

Atlanta, Georgia 30322

United States

Children's Center for Digestive Healthcare

Atlanta, Georgia 30342

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

University of Utah

Salt Lake City, Utah 84113

United States

Instituto Caici

Rosario, S2003CVB

Argentina

The Kids Research Institute Australia on behalf of the Centre for Child Health Research

Nedlands, 6009

Australia

Mater Hospital Brisbane Inflammatory Bowel Diseases

South Brisbane, 4101

Australia

The Children's Hospital at Westmead

Westmead, 2145

Australia

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, 74605 020

Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

Capital Center For Children's health Capital Medical University

Beijing, 100020

China

Changzhou No 2 Peoples Hospital

Changzhou, 213003

China

The Childrens Hospital Zhejiang University School Of Medicine

Hangzhou, 310005

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016

China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025

China

Shengjing Hospital Of China Medical University

Shenyang, 110055

China

Hospital Center University De Lille

Lille, 59000

France

Schon Klinik Hamburg Eilbek

Hamburg, 22081

Germany

Asklepios Klinik Sankt Augustin

Sankt Augustin, 53757

Germany

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127

Italy

Azienda USL di Bologna - Ospedale Maggiore

Bologna, 40121

Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165

Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013

Italy

IRCCS Materno Infantile Burlo Garofolo

Trieste, 34137

Italy

Tokyo Metropolitan Children's Medical Center

Fuchū, 183 8561

Japan

Kanazawa University Hospital

Kanazawa, 920 8641

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861 8520

Japan

Shinshu University Hospital

Matsumoto, 390 8621

Japan

Saga University Hospital

Saga, 849 0937

Japan

Yokohama City University Medical Center

Yokohama, 232 0024

Japan

Akershus Universitetssykehus

Akershus, 1478

Norway

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302

Poland

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o

Sosnowiec, 41 200

Poland

Medical Network

Warsaw, 04-501

Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, 04-730

Poland

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319

Portugal

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Gazi University Medical Faculty

Ankara, 06560

Turkey (Türkiye)

Umraniye Training and Research Hospital

Istanbul, 34764

Turkey (Türkiye)

Kocaeli Universitesi Hastanesi

Kocaeli, 41380

Turkey (Türkiye)

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG

United Kingdom

Haywood Hospital

Stoke-on-Trent, ST6 7AG

United Kingdom