RecruitingPhase 3NCT06663332

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

A Phase 3, Multicenter, Open-label, Basket, LTE Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Sponsor

Janssen Research & Development, LLC

Enrollment

196 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Crohns Disease

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

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for children who have already been part of a previous clinical trial testing guselkumab — a drug that blocks a protein called IL-23 involved in inflammation — for conditions such as psoriasis or psoriatic arthritis. The goal is to continue monitoring safety and effectiveness over the longer term. **You may be eligible if...** - Your child has already completed the dosing phase of the primary guselkumab pediatric study - The study doctor believes your child is still benefiting from continued treatment - Your child (and you as parent or guardian) are willing to consent and continue participation **You may NOT be eligible if...** - Your child is 18 or older AND lives in a country where the drug has been approved for adults for more than 2 years - Your child is under 18 AND lives in a country where the drug has been approved for pediatric use - Your child or guardian is unwilling to continue study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGuselkumab

Guselkumab will be administered as subcutaneous injection.

Locations(38)

Emory University

Atlanta, Georgia, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Utah

Salt Lake City, Utah, United States

Instituto Caici

Rosario, Argentina

Mater Hospital Brisbane Inflammatory Bowel Diseases

South Brisbane, Australia

Capital Center For Children's health Capital Medical University

Beijing, China

Changzhou No 2 Peoples Hospital

Changzhou, China

The Childrens Hospital Zhejiang University School Of Medicine

Hangzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

Shengjing Hospital Of China Medical University

Shenyang, China

Hospital Center University De Lille

Lille, France

Schon Klinik Hamburg Eilbek

Hamburg, Germany

Asklepios Klinik Sankt Augustin

Sankt Augustin, Germany

ASST Papa Giovanni XXIII Bergamo

Bergamo, Italy

Azienda USL di Bologna - Ospedale Maggiore

Bologna, Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, Italy

IRCCS Materno Infantile Burlo Garofolo

Trieste, Italy

Tokyo Metropolitan Children's Medical Center

Fuchū, Japan

Kanazawa University Hospital

Kanazawa, Japan

Kobe University Hospital

Kobe, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan

Shinshu University Hospital

Matsumoto, Japan

Saga University Hospital

Saga, Japan

Yokohama City University Medical Center

Yokohama, Japan

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

Sosnowiec, Poland

Medical Network

Warsaw, Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Severance Hospital Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Kocaeli Universitesi Hastanesi

Kocaeli, Turkey (Türkiye)

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06663332

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