A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

CompletadoFase 3ClinicalTrials.gov

ID: NCT03899259Tipo: INTERVENTIONALInicio: 8 de jul de 2019Fin estimado: 19 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
Have severe or very severe AA, as determined by all of the following:
Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.
No spontaneous improvement over the past 6 months.
Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very 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.
Male or nonpregnant, nonbreastfeeding female participants.

Criterios de exclusión

Primarily "diffuse" type of AA.
Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).

Intervenciones

drug

Baricitinib

Administered orally

drug

Placebo

Administered orally

Ubicaciones

Stat Research

CABA, Buenos Aires, Argentina

Instituto de Neumonología y Dermatología

Capital Federal, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Buenos Aires Skin

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Respirar

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Parra Dermatología

Mendoza, Argentina

Patrocinadores

PrincipalEli Lilly and Company

ColaboradorIncyte Corporation

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