Last updated 2 months ago
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
595 patients around the world
Available in Spain, Argentina, Mexico, United States
Eli Lilly and Company
13Research sites
595Patients around the world
This study is for people with
Alopecia
Alopecia areata
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.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.
- 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.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Centro Médico Privado de Reumatología - San Miguel de Tucumán
Recruiting
Psoriahue Medicina Interdisciplinaria - CABA, Buenos Aires
Recruiting
Fundación Respirar
Hospital del Niño Jesus - Tucumán
Recruiting
Centro Médico - Buenos Aires Skin S.A. - CABA, Buenos Aires
Recruiting
Hospital Universitario Austral - Pilar
Eukarya PharmaSite
CATEI - Centro de Atención en Enfermedades Inflamatorias
Hospital Universitario Dr. José Eleuterio González
StudyBRAVE-AA-PEDS
SponsorEli Lilly and Company
Conditions
Alopecia areata
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05723198
