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Recruiting Phase 3 NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Phase 3 – large-scale trial before approval
Conditions: Crohns Disease Colitis, Ulcerative Arthritis, Psoriatic Arthritis, Juvenile

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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 participate
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
Locations 13
Argentina (1)
Instituto Caici
Rosario
Australia (1)
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane
China (1)
Capital Center For Children's health Capital Medical University
Beijing
France (1)
Hospital Center University De Lille
Lille
Germany (1)
Schon Klinik Hamburg Eilbek
Hamburg
Italy (1)
ASST Papa Giovanni XXIII Bergamo
Bergamo
Japan (1)
Tokyo Metropolitan Children's Medical Center
Fuchū
Poland (1)
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec
South Korea (1)
Severance Hospital Yonsei University Health System
Seoul
Spain (1)
Hosp. Clinico Univ. de Santiago
Santiago de Compostela
Turkey (1)
Gazi University Medical Faculty
Ankara
United Kingdom (1)
Royal Stoke University Hospital
Stoke-on-Trent
United States (1)
Emory University
Atlanta , Georgia
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
3 Years
Healthy volunteers
No
Start date
29.10.2024
Completion date
12.12.2031
Registry ID
NCT06663332
Source
anzctr
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