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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:
• 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.
Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Other Locations
Argentina
Instituto Caici
RECRUITING
Rosario
China
Capital Center For Children's health Capital Medical University
RECRUITING
Beijing
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Childrens Hospital Zhejiang University School Of Medicine
RECRUITING
Hangzhou
Ruijin Hospital Shanghai Jiao Tong University
RECRUITING
Shanghai
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
Germany
Schon Klinik Hamburg Eilbek
RECRUITING
Hamburg
Japan
Kanazawa University Hospital
RECRUITING
Kanazawa
Kobe University Hospital
RECRUITING
Kobe
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Saga University Hospital
RECRUITING
Saga
Poland
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Medical Network
RECRUITING
Warsaw
Spain
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Turkey
Gazi University Medical Faculty
RECRUITING
Ankara
Umraniye Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-10-29
Estimated Completion Date:2031-12-12
Participants
Target number of participants:196
Treatments
Experimental: Guselkumab (Every 8 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.
Experimental: Guselkumab (Every 4 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.