Find Hemorrhagic Proctocolitis Clinical Trials Near You
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 (38) 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
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Utah
University of Utah
RECRUITING
Salt Lake City
Other Locations
Argentina
Instituto Caici
RECRUITING
Rosario
Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases
RECRUITING
South Brisbane
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
France
Hospital Center University De Lille
RECRUITING
Lille
Germany
Schon Klinik Hamburg Eilbek
RECRUITING
Hamburg
Asklepios Klinik Sankt Augustin
RECRUITING
Sankt Augustin
Italy
ASST Papa Giovanni XXIII Bergamo
RECRUITING
Bergamo
Azienda USL di Bologna - Ospedale Maggiore
RECRUITING
Bologna
IRCCS Ospedale Pediatrico Bambino Gesu
RECRUITING
Roma
IRCCS Materno Infantile Burlo Garofolo
RECRUITING
Trieste
Japan
Tokyo Metropolitan Children's Medical Center
RECRUITING
Fuchū
Kanazawa University Hospital
RECRUITING
Kanazawa
Kobe University Hospital
RECRUITING
Kobe
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Shinshu University Hospital
RECRUITING
Matsumoto
Saga University Hospital
RECRUITING
Saga
Yokohama City University Medical Center
RECRUITING
Yokohama
Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
RECRUITING
Sosnowiec
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Medical Network
RECRUITING
Warsaw
Portugal
Uls Braga - Hosp. Braga
RECRUITING
Braga
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Turkey
Gazi University Medical Faculty
RECRUITING
Ankara
Umraniye Training and Research Hospital
RECRUITING
Istanbul
Kocaeli Universitesi Hastanesi
RECRUITING
Kocaeli
United Kingdom
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
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.