Estudio de Fase 3, Multicéntrico, Abierto, en Cesta, de E... | EligiMed

Estudio de Fase 3, Multicéntrico, Abierto, en Cesta, de Extensión a Largo Plazo para Evaluar la Seguridad de Guselkumab en Participantes Pediátricos con Enfermedad de Crohn, Colitis Ulcerosa o Artritis Psoriásica Juvenil

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06663332Tipo: INTERVENTIONALInicio: 29 de oct de 2024Fin estimado: 12 de dic de 2031

Gastroenterología Reumatología Pediatría

Resumen

El propósito de este estudio es evaluar la seguridad a largo plazo de guselkumab subcutáneo en participantes pediátricos con colitis ulcerosa de moderadamente a gravemente activa, enfermedad de Crohn de moderadamente a gravemente activa, o artritis psoriásica juvenil (APsJ).

Elegibilidad

Edad mínima: 3 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

Guselkumab

Guselkumab will be administered as subcutaneous injection.

Ubicaciones

Instituto Caici

Rosario, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.