A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05559359Tipo: INTERVENTIONALInicio: 18 de oct de 2022Fin estimado: 1 de dic de 2026

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
months if participants are ≥6 years of age
months if participants are 2 to \<6 years of age
months if participants are 6 months to \<2 years of age.
Have an EASI score ≥16 at the screening and baseline
Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
Have ≥10% BSA of AD involvement at the screening and baseline.

Criterios de exclusión

Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
Treatment with the following prior to the baseline:
An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
Treatment with a topical investigational drug within 2 weeks prior to the baseline.
Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Intervenciones

drug

Lebrikizumab

Administered SC

drug

Placebo

Placebo given SC

drug

Topical Corticosteroid (TCS)

TCS administered

Ubicaciones

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Instituto de Neumonología Y Dermatología

Buenos Aires, Argentina

Derma Internacional

Buenos Aires, Argentina

Psoriahue

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

Patrocinadores

PrincipalEli Lilly and Company

ColaboradorDermira, Inc.

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