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CompletedPhase 2/3

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

Key facts

Where
Bellaire, Beverly, Birmingham, Boston, Charleston, Chicago, Clarkston, Cleveland, Dallas, Encinitas, Exton, Fort Smith, Gahanna, Glenn Dale, Hershey, Houston, Irvine, Jacksonville, Los Angeles, Louisville, Macon, Miami, Minneapolis, Mobile, Murray, New Haven, Newnan, Orange Park, Pflugerville, Philadelphia, Pittsburgh, Plymouth Meeting, Portland, Portsmouth, Redwood City, Rochester, Sacramento, San Antonio, San Diego, Santa Monica, Seattle, Tampa, The Bronx, and Webster, United StatesSee the 50 sites
Phase
Phase 2/3

Where in United States

  • Bellaire DermatologyBellaire, United StatesNo longer taking part
  • ActivMed Practices and ResearchBeverly, United StatesNo longer taking part
  • University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesNo longer taking part
  • Massachusetts General HospitalBoston, United StatesNo longer taking part
  • Medical University of South CarolinaCharleston, United StatesNo longer taking part
  • Northwestern UniversityChicago, United StatesNo longer taking part
  • Clarkston Skin ResearchClarkston, United StatesNo longer taking part
  • Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
  • Modern Research AssociatesDallas, United StatesNo longer taking part
  • California Dermatology & Clinical Research InstituteEncinitas, United StatesNo longer taking part
  • Dermatology and Skin Surgery CenterExton, United StatesNo longer taking part
  • Johnson DermatologyFort Smith, United StatesNo longer taking part
  • OH State Univ College of MedGahanna, United StatesNo longer taking part
  • Callender Center for Clinical Research, LLC / ResearchGlenn Dale, United StatesNo longer taking part
  • Penn State Univ. Milton S. Hershey Medical CenterHershey, United StatesNo longer taking part
  • Center for Clinical StudiesHouston, United StatesNo longer taking part
  • Alliance Research CentersIrvine, United StatesNo longer taking part
  • University of CA IrvineIrvine, United StatesNo longer taking part
  • Solutions Through Advanced Research, IncJacksonville, United StatesNo longer taking part
  • Dermatology Research AssociatesLos Angeles, United StatesNo longer taking part
  • Forefront ResearchLouisville, United StatesNo longer taking part
  • Skin Care Physicians of GeorgiaMacon, United StatesNo longer taking part
  • University of MiamiMiami, United StatesNo longer taking part
  • University of Minnesota Medical SchoolMinneapolis, United StatesNo longer taking part
  • Coastal Clinical Research, IncMobile, United StatesNo longer taking part
  • University of Utah MidValley DematologyMurray, United StatesNo longer taking part
  • Yale University School Of MedicineNew Haven, United StatesNo longer taking part
  • Medaphase IncNewnan, United StatesNo longer taking part
  • Park Avenue DermatologyOrange Park, United StatesNo longer taking part
  • Austin Institute for Clinical ResearchPflugerville, United StatesNo longer taking part
  • Perelman Center for Advanced MedicinePhiladelphia, United StatesNo longer taking part
  • University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
  • Dermatology Associates of Plymouth MeetingPlymouth Meeting, United StatesNo longer taking part
  • NW Dermatology & Research Center, LLCPortland, United StatesNo longer taking part
  • OHSU Center for Health and HealingPortland, United StatesNo longer taking part
  • Oregon Medical Research CenterPortland, United StatesNo longer taking part
  • ActivMed Practices and ResearchPortsmouth, United StatesNo longer taking part
  • Stanford Health CareRedwood City, United StatesNo longer taking part
  • University of Rochester School of MedicineRochester, United StatesNo longer taking part
  • University of California Davis-DermatologySacramento, United StatesNo longer taking part
  • Dermatology Clinical Research Center of San AntonioSan Antonio, United StatesNo longer taking part
  • Texas Dermatology and Laser SpecialistsSan Antonio, United StatesNo longer taking part
  • University Clinical Trials, IncSan Diego, United StatesNo longer taking part
  • Mosaic DermatologySanta Monica, United StatesNo longer taking part
  • Dermatology AssociatesSeattle, United StatesNo longer taking part
  • ForCare Clinical ResearchTampa, United StatesNo longer taking part
  • Montefiore Medical CenterThe Bronx, United StatesNo longer taking part
  • Center for Clinical StudiesWebster, United StatesNo longer taking part

Trial details

Who runs it
Eli Lilly and Company
Trial code
NCT03570749
Record updated
16 April 2026
Original description
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.Read full original descriptionShow less

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Inclusion: Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent; Must self-identify as either Black or African American in race in the open label addenda; Have severe or very severe AA, as determined by all of the following:; Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline; No spontaneous improvement over the past 6 months; Current episode of severe or very severe AA of less than 8 years; Male or nonpregnant, nonbreastfeeding female participants.

Exclusion: Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA; Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment); Primarily "diffuse" type of AA.

ClinicalTrials.gov NCT03570749