A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Key facts
- Where
- Bexley, Birmingham, Boca Raton, Charleston, Charlotte, Chicago, Cincinnati, Clarkston, Cleveland, Coral Gables, Dallas, Doral, Encinitas, Exton, Fairfield, Grapevine, Hollywood, Indianapolis, Jacksonville, Los Angeles, Macon, Madison, Miami, Minneapolis, Murfreesboro, Murray, Norfolk, Omaha, Portland, Rockville, Saint Joseph, San Antonio, San Diego, San Francisco, Santa Ana, Scottsdale, Skokie, South Bend, Sugar Land, The Bronx, and Tulsa, United StatesSee the 44 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05723198, who can take part
Where in United States
- Bexley Dermatology ResearchBexley, United StatesContact: Matthew Zirwas (principal investigator)Taking people
- Total Skin and Beauty Dermatology Center, PCBirmingham, United StatesContact: James Krell (principal investigator)Taking people
- University of Alabama at BirminghamBirmingham, United StatesContact: Lauren Smith Cole (principal investigator)Not yet recruiting
- Skin Care Research, IncBoca Raton, United StatesContact: Ann Reed (principal investigator)Not yet recruiting
- Medical University of South CarolinaCharleston, United StatesContact: Lara Wine Lee (principal investigator)Taking people
- Dermatology Specialists of CharlotteCharlotte, United StatesContact: Deborah Nixon (principal investigator)Taking people
- OnSite Clinical SolutionsCharlotte, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesContact: Amy Paller (principal investigator)Not yet recruiting
- Cincinnati Childrens Hospital Medical CenterCincinnati, United StatesContact: Kalyani Marathe (principal investigator)Not yet recruiting
- Michigan Center for Research CompanyClarkston, United StatesContact: Wendy McFalda (principal investigator)Taking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesContact: Neil Korman (principal investigator)Not yet recruiting
- Florida Academic Centers Research and Education, LLCCoral Gables, United StatesNo longer taking part
- Dermatology Treatment and Research CenterDallas, United StatesContact: Ross Radusky (principal investigator)Not yet recruiting
- D&H Doral Research Center, LLCDoral, United StatesContact: Brent Schillinger (principal investigator)Not yet recruiting
- California Dermatology & Clinical Research InstituteEncinitas, United StatesContact: Stacy Smith (principal investigator)Not yet recruiting
- The Pennsylvania Centre for Dermatology, LLCExton, United StatesNo longer taking part
- Dermatology Physicians of ConnecticutFairfield, United StatesContact: Brittany Craiglow (principal investigator)Not yet recruiting
- Pediatric Dermatology of North TexasGrapevine, United StatesContact: Fred Ghali (principal investigator)Taking people
- Skin Care Research, IncHollywood, United StatesContact: Eduardo Weiss (principal investigator)Not yet recruiting
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesContact: Kenneth Dawes (principal investigator)Taking people
- Solutions Through Advanced Research, IncJacksonville, United StatesContact: Pearl Kwong (principal investigator)Taking people
- Dermatology Research AssociatesLos Angeles, United StatesContact: Howard Sofen (principal investigator)Taking people
- Skin Care Physicians of GeorgiaMacon, United StatesContact: David Cohen (principal investigator)Taking people
- University of Wisconsin - MadisonMadison, United StatesContact: Lisa Arkin (principal investigator)Taking people
- Pediatric Skin Research LlcMiami, United StatesContact: Mercedes Gonzalez (principal investigator)Taking people
- University of Miami Miller School of MedicineMiami, United StatesContact: Mariya Miteva (principal investigator)Not yet recruiting
- University of Minnesota Medical SchoolMinneapolis, United StatesContact: Maria Hordinsky (principal investigator)Taking people
- International Clinical Research - Tennessee (IC Research)Murfreesboro, United StatesContact: Christina Feser (principal investigator)Taking people
- University of Utah MidValley DematologyMurray, United StatesContact: Jamie Rhoads (principal investigator)Not yet recruiting
- Virginia Clinical ResearchNorfolk, United StatesContact: David Pariser (principal investigator)Taking people
- Advanced Skin Research CenterOmaha, United StatesContact: Joel Schlessinger (principal investigator)Taking people
- Northwest Dermatology InstitutePortland, United StatesContact: Nisha Desai (principal investigator)Taking people
- DermAssociates, PCRockville, United StatesContact: Benjamin Lockshin (principal investigator)Taking people
- Medisearch Clinical TrialsSaint Joseph, United StatesContact: MELODY STONE (principal investigator)Taking people
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesContact: John Browning (principal investigator)Taking people
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent DermatologySan Diego, United StatesContact: Dawn Eichenfield (principal investigator)Taking people
- The Permanente Medical Group, Inc.San Francisco, United StatesContact: Paradi Mirmirani (principal investigator)Taking people
- Southern California Dermatology, Inc.Santa Ana, United StatesContact: Jennifer Soung (principal investigator)Taking people
- Investigate MdScottsdale, United StatesContact: Brenda LaTowsky (principal investigator)Taking people
- NorthShore University HealthSystemSkokie, United StatesContact: Joel Joyce (principal investigator)Taking people
- The South Bend Clinic Center for ResearchSouth Bend, United StatesContact: Holly Hake Harris (principal investigator)Taking people
- Complete DermatologySugar Land, United StatesContact: Vandana Madkan (principal investigator)Taking people
- Montefiore Medical CenterThe Bronx, United StatesContact: Holly Kanavy (principal investigator)Taking people
- Vital Prospects Clinical Research Institute, P.C.Tulsa, United StatesContact: Iftikhar Hussain (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT05723198EU 2022-502700-78-00
- Record updated
- 4 November 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Have had major surgery within 8 weeks prior to screening or will require major surgery during the study; Have uncontrolled arterial hypertension; 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; Primarily "diffuse" type of AA (characterized by diffuse hair shedding); Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden.