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A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
595
Start Date
2023-02-27
Completion Date
2033-09
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
Administered orally
Placebo
Administered orally
Locations (127)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Investigate MD
Scottsdale, Arizona, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Dermatology Research Associates
Los Angeles, California, United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, United States
The Permanente Medical Group, Inc.
San Francisco, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
Dermatology Physicians of Connecticut
Fairfield, Connecticut, United States
Skin Care Research, Inc
Boca Raton, Florida, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
D&H Doral Research Center LLC
Doral, Florida, United States
Skin Care Research, Inc
Hollywood, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Pediatric Skin Research, LLC
Miami, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northshore University Healthsystem
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The South Bend Clinic Center for Research
South Bend, Indiana, United States
DermAssociates PC.
Rockville, Maryland, United States
Michigan Center for Research Company
Clarkston, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Advanced Skin Research Center
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
OnSite Clinical Solutions
Charlotte, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Northwest Dermatology Institute
Portland, Oregon, United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Pediatric Dermatology of North Texas
Grapevine, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Complete Dermatology
Sugar Land, Texas, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Psoriahue Medicina Interdisciplinaria
Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
Derma Internacional SA
Buenos Aires, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, Argentina
Instituto de Neumonología Y Dermatología
Ciudad Autonoma Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Argentina
Hospital del Niño Jesus
San Miguel de Tucumán, Argentina
Skin and Cancer Foundation Australia - Darlinghurst Clinic
Darlinghurst, Australia
Sinclair Dermatology
Melbourne, Australia
Institute for Skin, Health, and Immunity
Mitcham, Australia
Veracity Clinical Research Pty Ltd
Wooloongabba, Australia
Dermatology Research Institute
Calgary, Canada
Skin Health
Cobourg, Canada
Lynderm Research Inc.
Markham, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, Canada
Research Toronto
Toronto, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Canada
CHRU de Brest - Hôpital Morvan
Brest, France
AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
Marseille, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France
Centre de Sante Sabouraud
Paris, France
Hôpital Clocheville Chru-Tours Département Dermatologie
Tours, France
Fachklinik Bad Bentheim
Bad Bentheim, Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Germany
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, Germany
Klinikum Rechts der Isar der TU München
München, Germany
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
Münster, Germany
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Pecsi Tudomanyegyetem
Pécs, Hungary
Hamamatsu University Hospital
Hamamatsu, Japan
Kurume University Hospital
Kurume, Japan
Kyorin University Hospital
Mitaka, Japan
Rifu Dermatology Allergy Clinic
Miyagi-gun, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
Osaka City University Hospital
Osaka, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Japan
Yamaguchi University Hospital
Ube, Japan
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
CareClinic
Katowice, Poland
Centrum Medyczne Angelius Provita
Katowice, Poland
Gabinet Dermatologiczny
Kielce, Poland
Specjalistyczny Gabinet Dermatologiczny s.c.
Krakow, Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Poland
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, Poland
DERMEDIC Jacek Zdybski
Swietokrzyski, Poland
Provita Poliklinika Sp. z o.o.
Warsaw, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, Poland
Centrum Medyczne Evimed
Warsaw, Poland
Klinika Ambroziak Sp. Z.O.O.
Warsaw, Poland