N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT05723198

Registry updated: 2026-09-08
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Baricitinib (Drug)
    Administered orally
  • Placebo (Drug)
    Administered orally

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.

Conditions

Areata Alopecia Alopecia Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical

Locations

  • 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
  • CityClinic Przychodnia Lekarsko-Psychologiczna — Wroclaw, Poland
  • Pusan National University Hospital — Busan, South Korea
  • Dankook University Hospital — Cheonan-si, South Korea
  • Chungnam national university hospital — Daejeon, South Korea
  • Inha University Hospital — Incheon, South Korea
  • Jeonbuk National University Hospital — Jeonju, South Korea
  • Kyungpook National University Hospital — Junggu, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Konkuk University Medical Center — Seoul, South Korea
  • Kyunghee University Hospital at Gangdong — Seoul, South Korea
  • Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH) — Seoul, South Korea
  • Ajou University Hospital — Suwon, South Korea
  • Hospital Universitario Germans Trias i Pujol — Badalona, Spain
  • Parc de Salut Mar - Hospital del Mar — Barcelona, Spain
  • Hospital Universitario Basurto — Bilbao (Bizkaia), Spain
  • Clinica Pedro Jaen — Madrid, Spain
  • Hospital Universitario Infanta Leonor-INTERNAL MED — Madrid, Spain
  • Hospital General Universitario de Valencia — Valencia, Spain
  • Taipei Medical University Shuang Ho Hospital — New Taipei City, Taiwan
  • Chung Shan Medical University Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record