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

Recruiting now · Phase 3

Conditions studied: Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile

In brief

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).

Key facts

Study ID

NCT06663332

Run by

Janssen Research & Development, LLC

People needed

196

Starts

2024-10-29

Expected to finish

2032-02-25

Last updated by the study team

2026-07-31

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Emory University — Atlanta, Georgia, United States (enrolling)
• Children's Center for Digestive Healthcare — Atlanta, Georgia, United States (enrolling)
• Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Instituto Caici — Rosario, Argentina (enrolling)
• The Kids Research Institute Australia on behalf of the Centre for Child Health Research — Nedlands, Australia (enrolling)
• Mater Hospital Brisbane Inflammatory Bowel Diseases — South Brisbane, Australia (enrolling)
• The Children's Hospital at Westmead — Westmead, Australia (enrolling)
• Universidade Federal de Goias - Hospital das Clinicas da UFG — Goiânia, Brazil (enrolling)
• INTEGRAL Pesquisa e Ensino — Votuporanga, Brazil (enrolling)
• Capital Center For Children's health Capital Medical University — Beijing, China (enrolling)
• Changzhou No 2 Peoples Hospital — Changzhou, China (enrolling)
• The Childrens Hospital Zhejiang University School Of Medicine — Hangzhou, China (enrolling)
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• Ruijin Hospital Shanghai Jiao Tong University — Shanghai, China (enrolling)
• Shengjing Hospital Of China Medical University — Shenyang, China (enrolling)
• Hospital Center University De Lille — Lille, France (enrolling)
• Schon Klinik Hamburg Eilbek — Hamburg, Germany (enrolling)
• Asklepios Klinik Sankt Augustin — Sankt Augustin, Germany (enrolling)
• ASST Papa Giovanni XXIII Bergamo — Bergamo, Italy (enrolling)
• Azienda USL di Bologna - Ospedale Maggiore — Bologna, Italy (enrolling)
• IRCCS Ospedale Pediatrico Bambino Gesu — Roma, Italy (enrolling)
• Casa Sollievo Della Sofferenza IRCCS — San Giovanni Rotondo, Italy (enrolling)
• IRCCS Materno Infantile Burlo Garofolo — Trieste, Italy (enrolling)

Full record on ClinicalTrials.gov

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