A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)
Areata Alopecia, Alopecia, Hypotrichosis
About this trial
This is an interventional treatment trial for Areata Alopecia
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 / Locations
- Total Skin and Beauty Dermatology Center, PCRecruiting
- Investigate MDRecruiting
- California Dermatology & Clinical Research Institute
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
- Southern California Dermatology, Inc.
- Skin Care Research, Inc
- Florida Academic Centers Research and Education, LLCRecruiting
- Pediatric Skin Research, LLCRecruiting
- D&H Doral Research Center LLC
- Skin Care Research, Inc
- Solutions Through Advanced ResearchRecruiting
- ForCare Clinical Research
- Skin Care Physicians of GeorgiaRecruiting
- Dawes Fretzin Clinical Research Group, LLCRecruiting
- The South Bend Clinic Center for ResearchRecruiting
- Dermatology and Skin Cancer Specialists, LLCRecruiting
- Great Lakes Research Group, Inc.
- Clarkston Skin ResearchRecruiting
- MediSearch Clinical Trials
- Advanced Skin Research CenterRecruiting
- Montefiore Medical Center
- Dermatology Specialists of Charlotte
- OnSite Clinical Solutions
- Bexley Dermatology ResearchRecruiting
- University Hospitals Cleveland Medical Center
- Vital Prospects Clinical Research Institute, PCRecruiting
- NW Dermatology & Research Center, LLC
- The Pennsylvania Centre for Dermatology, LLCRecruiting
- International Clinical ResearchRecruiting
- Dermatology Treatment and Research Center
- Pediatric Dermatology of North TexasRecruiting
- Austin Institute for Clinical Research
- Texas Dermatology and Laser SpecialistsRecruiting
- Complete DermatologyRecruiting
- University of Utah MidValley Dematology
- Virginia Clinical Research, Inc.Recruiting
- University of Wisconsin-Madison
- The Skin Hospital
- Royal North Shore Hospital
- Veracity Clinical Research Pty LtdRecruiting
- Sinclair Dermatology
- Institute for Skin, Health, and Immunity
- CHRU de Brest - Hôpital Morvan
- AP-HM CHU Timone
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
- CHU de Nice Hopital de L'Archet
- Centre de Sante Sabouraud
- Centre de Sante Sabouraud
- Fachklinik Bad Bentheim
- University Hospital Carl Gustav Carus
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
- Universitätsklinik und Poliklinik für Dermatologie und Venerologie
- Universitaetsklinikum Hamburg-Eppendorf
- Catholic Children's Hospital Wilhelmstift
- Universitaetsklinikum Schleswig-Holstein
- Dermatologische Gemeinschaftspraxis Dres. Quist
- Klinikum Rechts der Isar der TU Muenchen
- Klinikum Rechts der Isar der TU Muenchen
- University of Muenster
- University of Szeged
- Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
- Somogy Megyei Kaposi Mór Oktató Kórház
- Clinexpert Tatabánya Ltd.
- Pecsi Tudomanyegyetem Klinikai Kozpont
- Kurume University HospitalRecruiting
- Hamamatsu University Hospital
- Kyorin University Hospital
- Tokyo Medical University HospitalRecruiting
- Yamaguchi University HospitalRecruiting
- Niigata University Medical & Dental HospitalRecruiting
- Osaka City University Hospital
- Dankook University Hospital
- Ajou University Hospital
- Chungnam University Hospital
- Kyung Pook National University Hospital
- Inha University Hospital
- Kyunghee University Hospital at Gangdong
- Pusan National University Hospital
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
- Seoul National University Hospital
- Jeonbuk National University Hospital
- Severance Hospital, Yonsei University Health System
- Chung-Ang University Hospital
- Konkuk University Medical Center
- Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Specjalistyczny Gabinet Dermatologiczny s.c.
- High-Med Przychodnia Specjalistyczna
- Centralny Szpital Kliniczny MSWiA w Warszawie
- NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
- Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
- Centrum Badan Klinicznych PI-House sp. z o.o.
- CareClinic
- Gabinet Dermatlogiczny. Beata Krecisz
- DERMEDIC Jacek Zdybski
- Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
- Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
- Centrum Medyczne Evimed
- Provita Poliklinika Sp. z o
- Royalderm Agnieszka Nawrocka
- Klinika Ambroziak Sp. Z.O.O.
- CityClinic Przychodnia Lekarsko-Psychologiczna
- Centrum Medyczne Angelius Provita
- Hospital De Basurto
- Hospital General Universitario de Alicante
- Hospital Universitari Germans Trias i Pujol (HUGTP)
- Hospital del Mar
- Clinica Pedro Jaen
- Hospital Universitario Infanta Leonor
- Hospital Universitario 12 de Octubre
- Clinica Universidad de Navarra
- Hospital Universitario Quiron Salud Madrid
- ERESA-Hospital General Valencia
- Taipei Medical University Shuang Ho Hospital
- Chung Shan Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital - Taipei
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Baricitinib High Dose
Baricitinib Low Dose
Placebo
Participants will receive baricitinib high dose orally.
Participants will receive baricitinib low dose orally.
Participants will receive placebo