A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Recruiting · NCT06663332 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
3 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 4 US states.
- Emory University - Atlanta, Georgia, United States
- Children's Center for Digestive Healthcare - Atlanta, Georgia, United States
- Emory University - Atlanta, Georgia, United States
- Children's Center for Digestive Healthcare - Atlanta, Georgia, United States
- Emory University - Atlanta, Georgia, United States
- Children's Center for Digestive Healthcare - Atlanta, Georgia, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- University of Utah - Salt Lake City, Utah, United States
- University of Utah - Salt Lake City, Utah, United States
- University of Utah - Salt Lake City, Utah, United States
- Akershus Universitetssykehus - Akershus, Norway
- Akershus Universitetssykehus - Akershus, Norway
- Akershus Universitetssykehus - Akershus, Norway
- Gazi University Medical Faculty - Ankara, Turkey (Türkiye)
- Gazi University Medical Faculty - Ankara, Turkey (Türkiye)
- Gazi University Medical Faculty - Ankara, Turkey (Türkiye)
- Capital Center For Children's health Capital Medical University - Beijing, China
- Capital Center For Children's health Capital Medical University - Beijing, China
- Capital Center For Children's health Capital Medical University - Beijing, China
- ASST Papa Giovanni XXIII Bergamo - Bergamo, Italy
- ASST Papa Giovanni XXIII Bergamo - Bergamo, Italy
- ASST Papa Giovanni XXIII Bergamo - Bergamo, Italy
- Azienda USL di Bologna - Ospedale Maggiore - Bologna, Italy
- Azienda USL di Bologna - Ospedale Maggiore - Bologna, Italy
- Azienda USL di Bologna - Ospedale Maggiore - Bologna, Italy
- Uls Braga - Hosp. Braga - Braga, Portugal
- Uls Braga - Hosp. Braga - Braga, Portugal
- Uls Braga - Hosp. Braga - Braga, Portugal
- Changzhou No 2 Peoples Hospital - Changzhou, China
- Changzhou No 2 Peoples Hospital - Changzhou, China
- Changzhou No 2 Peoples Hospital - Changzhou, China
- Tokyo Metropolitan Children's Medical Center - Fuchū, Japan
- Tokyo Metropolitan Children's Medical Center - Fuchū, Japan
- Tokyo Metropolitan Children's Medical Center - Fuchū, Japan
- Hospital das Clinicas - UFG - Goiânia, Brazil
- Hospital das Clinicas - UFG - Goiânia, Brazil
- Hospital das Clinicas - UFG - Goiânia, Brazil
- Schon Klinik Hamburg Eilbek - Hamburg, Germany
- Schon Klinik Hamburg Eilbek - Hamburg, Germany
- Schon Klinik Hamburg Eilbek - Hamburg, Germany
- The Childrens Hospital Zhejiang University School Of Medicine - Hangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- The Childrens Hospital Zhejiang University School Of Medicine - Hangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- The Childrens Hospital Zhejiang University School Of Medicine - Hangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- Umraniye Training and Research Hospital - Istanbul, Turkey (Türkiye)
- Umraniye Training and Research Hospital - Istanbul, Turkey (Türkiye)
- Umraniye Training and Research Hospital - Istanbul, Turkey (Türkiye)
- Kanazawa University Hospital - Kanazawa, Japan
- Kanazawa University Hospital - Kanazawa, Japan
- Kanazawa University Hospital - Kanazawa, Japan
- Kobe University Hospital - Kobe, Japan
- Kobe University Hospital - Kobe, Japan
- Kobe University Hospital - Kobe, Japan
Showing 60 of 147 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →