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Clinical Trials in the USA / NCT06663332
Recruiting Phase 3

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

NCT06663332 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-10-29
Last updated
2026-08-28

Condition(s) studied

Crohns DiseaseColitis, UlcerativeArthritis, PsoriaticArthritis, Juvenile

Investigational drug(s) / intervention(s)

Guselkumab

Guselkumab: Guselkumab will be administered as subcutaneous injection.

Study 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

Sex
ALL
Min age
3 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Emory University Atlanta Georgia Recruiting
Children's Center for Digestive Healthcare Atlanta Georgia Recruiting
Riley Hospital for Children Indianapolis Indiana Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
University of Utah Salt Lake City Utah Recruiting
Instituto Caici Rosario Argentina Recruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research Nedlands Australia Recruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases South Brisbane Australia Recruiting
The Children's Hospital at Westmead Westmead Australia Recruiting
Hospital das Clinicas - UFG Goiânia Brazil Recruiting
INTEGRAL Pesquisa e Ensino Votuporanga Brazil Recruiting
Capital Center For Children's health Capital Medical University Beijing China Recruiting
Changzhou No 2 Peoples Hospital Changzhou China Recruiting
The Childrens Hospital Zhejiang University School Of Medicine Hangzhou China Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou China Recruiting
Ruijin Hospital Shanghai Jiao Tong University Shanghai China Recruiting
Shengjing Hospital Of China Medical University Shenyang China Recruiting
Hospital Center University De Lille Lille France Recruiting
Schon Klinik Hamburg Eilbek Hamburg Germany Recruiting
Asklepios Klinik Sankt Augustin Sankt Augustin Germany Recruiting
ASST Papa Giovanni XXIII Bergamo Bergamo Italy Recruiting
Azienda USL di Bologna - Ospedale Maggiore Bologna Italy Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu Roma Italy Recruiting
Casa Sollievo Della Sofferenza IRCCS San Giovanni Rotondo Italy Recruiting
IRCCS Materno Infantile Burlo Garofolo Trieste Italy Recruiting
Tokyo Metropolitan Children's Medical Center Fuchū Japan Recruiting
Kanazawa University Hospital Kanazawa Japan Recruiting
Kobe University Hospital Kobe Japan Recruiting
Japanese Red Cross Kumamoto Hospital Kumamoto Japan Recruiting
Shinshu University Hospital Matsumoto Japan Recruiting
Saga University Hospital Saga Japan Recruiting
Yokohama City University Medical Center Yokohama Japan Recruiting
Akershus Universitetssykehus Akershus Norway Recruiting
Korczowski Bartosz Gabinet Lekarski Rzeszów Poland Recruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o Sosnowiec Poland Recruiting
Medical Network Warsaw Poland Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland Recruiting
Uls Braga - Hosp. Braga Braga Portugal Recruiting
Uls Sao Joao - Hosp. Sao Joao Porto Portugal Recruiting
Severance Hospital Yonsei University Health System Seoul South Korea Recruiting

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06663332 on ClinicalTrials.gov ↗ ← All trials in the USA