A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Study Purpose
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 Period, and a 4-week Post-treatment Follow-up period.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 6 Years - 17 Years |
Gender | All |
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05723198 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
Principal Investigator Affiliation | Eli Lilly and Company |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Canada, France, Germany, Hungary, Japan, Korea, Republic of, Mexico, Poland, Spain, Taiwan, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical |
Study Website: | View Trial Website |
Arms
Experimental: Baricitinib High Dose
Participants will receive baricitinib high dose orally.
Experimental: Baricitinib Low Dose
Participants will receive baricitinib low dose orally.
Placebo Comparator: Placebo
Participants will receive placebo
Interventions
Drug: - Baricitinib
Administered orally
Drug: - Placebo
Administered orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Status
Not yet recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Status
Recruiting
Address
Investigate MD
Scottsdale, Arizona, 85255
Status
Not yet recruiting
Address
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Status
Recruiting
Address
Dermatology Research Associates
Los Angeles, California, 90045
Status
Recruiting
Address
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123
Status
Not yet recruiting
Address
The Permanente Medical Group, Inc.
San Francisco, California, 94118
Status
Recruiting
Address
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Status
Not yet recruiting
Address
Dermatology Physicians of Connecticut
Fairfield, Connecticut, 06824
Status
Not yet recruiting
Address
Skin Care Research, Inc
Boca Raton, Florida, 33486
Status
Recruiting
Address
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Status
Recruiting
Address
Pediatric Skin Research, LLC
Coral Gables, Florida, 33146
Status
Not yet recruiting
Address
D&H Doral Research Center LLC
Doral, Florida, 33122
Status
Not yet recruiting
Address
Skin Care Research, Inc
Hollywood, Florida, 33021
Status
Recruiting
Address
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Status
Not yet recruiting
Address
University of Miami Miller School of Medicine
Miami, Florida, 33125
Status
Not yet recruiting
Address
ForCare Clinical Research
Tampa, Florida, 33613-1244
Status
Recruiting
Address
Skin Care Physicians of Georgia
Macon, Georgia, 31217
Status
Not yet recruiting
Address
Northwestern University
Chicago, Illinois, 60611
Status
Recruiting
Address
NorthShore University HealthSystem
Skokie, Illinois, 60077
Status
Recruiting
Address
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Status
Recruiting
Address
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
Status
Recruiting
Address
DermAssociates PC.
Rockville, Maryland, 20850
Status
Not yet recruiting
Address
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Status
Recruiting
Address
Michigan Center for Research Company
Clarkston, Michigan, 48346
Status
Not yet recruiting
Address
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Status
Recruiting
Address
Advanced Skin Research Center
Omaha, Nebraska, 68144
Status
Not yet recruiting
Address
Montefiore Medical Center
Bronx, New York, 10467
Status
Recruiting
Address
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
Status
Recruiting
Address
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
Status
Recruiting
Address
Bexley Dermatology Research
Bexley, Ohio, 43209
Status
Not yet recruiting
Address
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Not yet recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Recruiting
Address
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
Status
Recruiting
Address
Northwest Dermatology Institute
Portland, Oregon, 97210
Status
Recruiting
Address
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
International Clinical Research
Murfreesboro, Tennessee, 37130
Status
Not yet recruiting
Address
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Status
Recruiting
Address
Pediatric Dermatology of North Texas
Grapevine, Texas, 76051
Status
Not yet recruiting
Address
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Status
Recruiting
Address
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Status
Recruiting
Address
Complete Dermatology
Sugar Land, Texas, 77479
Status
Not yet recruiting
Address
University of Utah MidValley Dematology
Murray, Utah, 84107
Status
Recruiting
Address
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Status
Recruiting
Address
University of Wisconsin-Madison
Madison, Wisconsin, 53715
International Sites
Status
Recruiting
Address
Centro de Investigaciones Metabólicas (CINME)
Caba, Buenos Aires, C1027AAP
Status
Recruiting
Address
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, Buenos Aires, C1055AA0
Status
Recruiting
Address
Instituto de Neumonología Y Dermatología
Ciudad Autonoma Buenos Aires, Buenos Aires, C1425BEA
Status
Not yet recruiting
Address
Hospital Universitario Austral
Pilar, Buenos Aires, 1629
Status
Not yet recruiting
Address
Fundación Respirar
Buenos Aires, Buenos Air, C1426ABP
Status
Recruiting
Address
Hospital del Niño Jesus
San Miguel de Tucuman, Provincia De Tucuman, 4000
Status
Recruiting
Address
Centro Medico Privado de Reumatologia
San Miguel De Tucumán, Tucumán, T4000AXL
Status
Recruiting
Address
Psoriahue Medicina Interdisciplinaria
Buenos Aires, , C1425DKG
Status
Recruiting
Address
The Skin Hospital
Darlinghurst, New South Wales, 02010
Status
Not yet recruiting
Address
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Status
Recruiting
Address
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Sinclair Dermatology
Melbourne, Victoria, 3002
Status
Recruiting
Address
Institute for Skin, Health, and Immunity
Mitcham, Victoria, 3132
Status
Not yet recruiting
Address
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Status
Recruiting
Address
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Status
Recruiting
Address
Skin Health
Cobourg, Ontario, K9A 0Z4
Status
Recruiting
Address
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
Status
Recruiting
Address
Research Toronto
Toronto, Ontario, M4W 2N2
Status
Not yet recruiting
Address
CHRU de Brest - Hôpital Morvan
Brest CEDEX 2, , 29609
Status
Not yet recruiting
Address
AP-HM CHU Timone
Marseille, , 13005
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, , 44093
Status
Recruiting
Address
CHU de Nice Hopital de L'Archet
Nice, , 6202
Status
Recruiting
Address
Centre de Sante Sabouraud
Paris, , 75010
Status
Recruiting
Address
Hôpital Clocheville Chru-Tours Département Dermatologie
Tours Cedex, , 37044
Status
Not yet recruiting
Address
Klinikum Rechts der Isar der TU Muenchen
Muenchen, Bayern, 80802
Status
Recruiting
Address
Fachklinik Bad Bentheim
Bad Bentheim, Niedersachsen, 48455
Status
Not yet recruiting
Address
Universitaetsklinikum Schleswig-Holstein
Luebeck, Schleswig-Holstein, 23538
Status
Recruiting
Address
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , 10117
Status
Recruiting
Address
Universitätsklinikum Carl Gustav Carus
Dresden, , 01307
Status
Recruiting
Address
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Frankfurt am Main, , 60590
Status
Not yet recruiting
Address
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Halle, , 06120
Status
Not yet recruiting
Address
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , 20246
Status
Not yet recruiting
Address
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, , 22149
Status
Recruiting
Address
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, , 55128
Status
Not yet recruiting
Address
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
Muenster, , 48149
Status
Not yet recruiting
Address
University of Szeged
Szeged, Csongrad, 6720
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdu-Bihar, 4032
Status
Not yet recruiting
Address
Clinexpert Tatabánya Ltd.
Budapest, , 1033
Status
Recruiting
Address
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, , 7632
Status
Recruiting
Address
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Status
Recruiting
Address
Rifu Dermatology Allergy Clinic
Miyagi-gun, Miyagi, 981 0112
Status
Recruiting
Address
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Status
Not yet recruiting
Address
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Status
Recruiting
Address
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Status
Recruiting
Address
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Status
Recruiting
Address
Niigata University Medical & Dental Hospital
Niigata, , 951-8520
Status
Recruiting
Address
Osaka City University Hospital
Osaka, , 545-8586
Status
Recruiting
Address
Dankook University Hospital
Cheonan-si, Chungcheongnam-do [Chungnam], 31116
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam-si, Geonggi-do, 13620
Status
Recruiting
Address
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Status
Recruiting
Address
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], 22332
Status
Recruiting
Address
Chungnam University Hospital
Daejeon, Jung-gu, 34134
Status
Recruiting
Address
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, 49241
Status
Recruiting
Address
Kyunghee University Hospital at Gangdong
Seoul, Seoul, Korea, 05278
Status
Recruiting
Address
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Status
Recruiting
Address
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03312
Status
Recruiting
Address
Kyung Pook National University Hospital
Jung-gu, Taegu-Kwangyǒkshi, 41944
Status
Recruiting
Address
Jeonbuk National University Hospital
Jeonju-si, , 54907
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Recruiting
Address
Chung-Ang University Hospital
Seoul, , 06973
Status
Not yet recruiting
Address
Konkuk University Medical Center
Seoul, , 143729
Status
Not yet recruiting
Address
Grupo Clínico CATEI SC
Guadalajara, Jalisco, 44638
Status
Not yet recruiting
Address
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Status
Not yet recruiting
Address
Eukarya PharmaSite
Monterrey, Nuevo León, 64718
Status
Not yet recruiting
Address
Hospital Angeles Chihuahua Unidad de Investigacion Clinica
Chihuahua, , 31217
Status
Not yet recruiting
Address
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, , 14090
Status
Not yet recruiting
Address
Mexico Centre for Clinical Research
Mexico City, , 6720
Status
Not yet recruiting
Address
Arké SMO S.A de C.V
Veracruz, , 91910
Status
Recruiting
Address
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Lodzkie, 90-436
Status
Recruiting
Address
Specjalistyczny Gabinet Dermatologiczny s.c.
Krakow, Malopolskie, 30-002
Status
Not yet recruiting
Address
High-Med Przychodnia Specjalistyczna
Warsaw, Masovian, 01-817
Status
Recruiting
Address
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Małopolskie, 02-507
Status
Recruiting
Address
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszow, Podkarpackie, 35-055
Status
Recruiting
Address
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie, 80-546
Status
Not yet recruiting
Address
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
Bialystok, , 15-453
Status
Not yet recruiting
Address
Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
Bydgoszcz, , 85-065
Status
Recruiting
Address
CareClinic
Katowice, , 40-568
Status
Recruiting
Address
Gabinet Dermatlogiczny. Beata Krecisz
Kielce, , 25-155
Status
Recruiting
Address
DERMEDIC Jacek Zdybski
Ostrowiec Swietokrzyski, , 27-400
Status
Not yet recruiting
Address
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
Szczecin, , 70-332
Status
Recruiting
Address
Centrum Medyczne Evimed
Warszawa, , 02-625
Status
Recruiting
Address
Provita Poliklinika Sp. z o
Warszawa, , 02-647
Status
Recruiting
Address
Royalderm Agnieszka Nawrocka
Warszawa, , 02-692
Status
Recruiting
Address
Klinika Ambroziak Sp. Z.O.O.
Warszawa, , 02-953
Status
Recruiting
Address
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, , 50-566
Status
Recruiting
Address
Centrum Medyczne Angelius Provita
Katowice, Śląskie, 40-611
Status
Recruiting
Address
Hospital del Mar
Barcelona, Catalunya [Cataluña], 08003
Status
Not yet recruiting
Address
Hospital General Universitario de Alicante
Alicante, , 03010
Status
Not yet recruiting
Address
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, , 08916
Status
Recruiting
Address
Hospital Universitario Basurto
Bilbao, , 48013
Status
Recruiting
Address
Clinica Pedro Jaen
Madrid, , 28006
Status
Recruiting
Address
Hospital Universitario Infanta Leonor
Madrid, , 28031
Status
Not yet recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Not yet recruiting
Address
Clinica Universidad de Navarra
Pamplona, , 31008
Status
Not yet recruiting
Address
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcon, , 28223
Status
Recruiting
Address
Hospital General Universitario de Valencia
Valencia, , 46014
Status
Not yet recruiting
Address
Taipei Medical University Shuang Ho Hospital
New Taipei City, New Taipei, 235
Status
Recruiting
Address
Chung Shan Medical University Hospital
Taichung City, Taichung, 40201
Status
Not yet recruiting
Address
National Cheng Kung University Hospital
Tainan, , 70403
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Status
Not yet recruiting
Address
Taipei Veterans General Hospital
Taipei, , 11217
Status
Not yet recruiting
Address
Chang Gung Memorial Hospital - Taipei
Taoyuan, , 33305