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
Janssen Research & Development, LLC
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
- Age range
- 3+ years
- Sex
- All
- 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…
Interventions
- DrugGuselkumab
Guselkumab will be administered as subcutaneous injection.
Locations (42)
- Emory UniversityAtlanta, Georgia
- Children's Center for Digestive HealthcareAtlanta, Georgia
- Riley Hospital for ChildrenIndianapolis, Indiana
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- University of UtahSalt Lake City, Utah
- Instituto CaiciRosario