Ensayo clínico de fase 3, doble ciego, aleatorizado, cont... | EligiMed

Ensayo clínico de fase 3, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia, seguridad y farmacocinética (FC) de baricitinib en niños de 6 a menos de 18 años de edad con alopecia areata

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05723198Tipo: INTERVENTIONALInicio: 27 de feb de 2023Fin estimado: 1 de ago de 2029

Resumen

El objetivo principal de este estudio es determinar la eficacia y seguridad de baricitinib para el tratamiento de la alopecia areata grave o muy grave (caída del cabello) en niños de 6 a menos de 18 años de edad. El estudio se divide en 4 períodos: un período de tamizaje de 5 semanas, un período de tratamiento doble ciego de 36 semanas, un período de extensión a largo plazo de aproximadamente 2 años y un período de seguimiento postratamiento de 4 semanas.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
Have severe areata alopecia (AA) for at least 1 year
Diagnosis for at least 1 year
Current AA episode of at least 6 months' duration
SALT score ≥50% at screening and baseline
History of trial and failure with at least 1 available treatment (topical or other) for AA
History of psychological counseling related to AA
Current episode of severe AA of less than 8 years.
Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.

Criterios de exclusión

Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
Have uncontrolled arterial hypertension
Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
Have a positive test for hepatitis B virus (HBV) infection
Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]).
Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Intervenciones

drug

Baricitinib

Administered orally

drug

Placebo

Administered orally

Ubicaciones

Psoriahue Medicina Interdisciplinaria

Buenos Aires, Argentina

RECRUITING

Fundación Respirar

Buenos Aires, Argentina

RECRUITING

Derma Internacional SA

Buenos Aires, Argentina

RECRUITING

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Instituto de Neumonología Y Dermatología

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Hospital Universitario Austral

Pilar, Argentina

NOT_YET_RECRUITING

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, Argentina

COMPLETED

Hospital del Niño Jesus

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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.