A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Por invitaciónFase 3ClinicalTrials.gov

ID: NCT05735483Tipo: INTERVENTIONALInicio: 9 de mar de 2023Fin estimado: 1 de abr de 2029

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Criterios de exclusión

Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

Intervenciones

drug

Lebrikizumab

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Instituto de Neumonología Y Dermatología

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Psoriahue

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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