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

NCT06663332 · Janssen Research & Development, LLC
In plain English

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Official title
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
About this study
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
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
Study design
Enrollment target: 196 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-10-29
Estimated completion: 2031-12-12
Last updated: 2026-04-13
Interventions
Drug: Guselkumab
Primary outcomes
  • Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety (Up to 6 years and 9 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (38)
Emory UniversityRecruiting
Atlanta, Georgia, United States
Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
Instituto CaiciRecruiting
Rosario, Argentina
Mater Hospital Brisbane Inflammatory Bowel DiseasesRecruiting
South Brisbane, Australia
Capital Center For Children's health Capital Medical UniversityRecruiting
Beijing, China
Changzhou No 2 Peoples HospitalRecruiting
Changzhou, China
The Childrens Hospital Zhejiang University School Of MedicineRecruiting
Hangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
Hangzhou, China
Ruijin Hospital Shanghai Jiao Tong UniversityRecruiting
Shanghai, China
Shengjing Hospital Of China Medical UniversityRecruiting
Shenyang, China
Hospital Center University De LilleRecruiting
Lille, France
Schon Klinik Hamburg EilbekRecruiting
Hamburg, Germany
Asklepios Klinik Sankt AugustinRecruiting
Sankt Augustin, Germany
ASST Papa Giovanni XXIII BergamoRecruiting
Bergamo, Italy
Azienda USL di Bologna - Ospedale MaggioreRecruiting
Bologna, Italy
IRCCS Ospedale Pediatrico Bambino GesuRecruiting
Roma, Italy
IRCCS Materno Infantile Burlo GarofoloRecruiting
Trieste, Italy
Tokyo Metropolitan Children's Medical CenterRecruiting
Fuchū, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Japan
Kobe University HospitalRecruiting
Kobe, Japan
Japanese Red Cross Kumamoto HospitalRecruiting
Kumamoto, Japan
Shinshu University HospitalRecruiting
Matsumoto, Japan
Saga University HospitalRecruiting
Saga, Japan
Yokohama City University Medical CenterRecruiting
Yokohama, Japan
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o oRecruiting
Sosnowiec, Poland
Medical NetworkRecruiting
Warsaw, Poland
Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
Warsaw, Poland
Uls Braga - Hosp. BragaRecruiting
Braga, Portugal
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain
Hosp. Univ. I Politecni La FeRecruiting
Valencia, Spain
Gazi University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Umraniye Training and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Kocaeli Universitesi HastanesiRecruiting
Kocaeli, Turkey (Türkiye)
Royal Stoke University HospitalRecruiting
Stoke-on-Trent, United Kingdom
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants · TrialPath