Clinical trial NCT06663332: A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohns Disease
Colitis, Ulcerative
Arthritis, Psoriatic
Arthritis, Juvenile
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 196
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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: 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 outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
timeFrame: Up to 6 years and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Changzhou
country: China
facility: Changzhou No 2 Peoples Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Warszawa
country: Poland
facility: Medical Network
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Istanbul
country: Turkey
facility: Umraniye Training and Research Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: