A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Key facts
- Where
- Bay City, Bexley, Birmingham, Boston, Bridgeport, Chapel Hill, Charlotte, Chesterfield, Cleveland, Coral Gables, East Greenwich, Fort Gratiot, Fremont, Houston, Indianapolis, Mason, Miami, New Brighton, Norfolk, Northridge, Owensboro, Portland, Raleigh, Rockville, Saint Joseph, San Antonio, San Francisco, Scottsdale, South Bend, Tampa, Troy, and Tulsa, United StatesSee the 33 sites
- Phase
- Phase 3
Where in United States
- Great Lakes Research Group, Inc.Bay City, United StatesNo longer taking part
- Bexley Dermatology ResearchBexley, United StatesNo longer taking part
- Total Skin and Beauty Dermatology Center, PCBirmingham, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- New England Research AssociatesBridgeport, United StatesNo longer taking part
- The University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- Dermatology Specialists of CharlotteCharlotte, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLCChesterfield, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Florida Academic Centers Research and Education, LLCCoral Gables, United StatesNo longer taking part
- Velocity Clinical Research, ProvidenceEast Greenwich, United StatesNo longer taking part
- Hamzavi DermatologyFort Gratiot, United StatesNo longer taking part
- Center For Dermatology Clinical Research, Inc.Fremont, United StatesNo longer taking part
- Suzanne Bruce and Associates, PAHouston, United StatesNo longer taking part
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesNo longer taking part
- Dermatologists of Southwest OhioMason, United StatesNo longer taking part
- New Horizon Research CenterMiami, United StatesNo longer taking part
- Associated Skin Care SpecialistsNew Brighton, United StatesNo longer taking part
- Virginia Clinical Research, Inc.Norfolk, United StatesNo longer taking part
- Quest Dermatology ResearchNorthridge, United StatesNo longer taking part
- Qualmedica Research, LLCOwensboro, United StatesNo longer taking part
- Northwest Dermatology InstitutePortland, United StatesNo longer taking part
- Oregon Dermatology and Research CenterPortland, United StatesNo longer taking part
- M3-Emerging Medical ResearchRaleigh, United StatesNo longer taking part
- Dermatology and Skin Cancer SpecialistsRockville, United StatesNo longer taking part
- Medisearch Clinical TrialsSaint Joseph, United StatesNo longer taking part
- Progressive Clinical ResearchSan Antonio, United StatesNo longer taking part
- Kaiser Permanente HospitalSan Francisco, United StatesNo longer taking part
- Investigate MdScottsdale, United StatesNo longer taking part
- The South Bend Clinic Center for ResearchSouth Bend, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- Joseph J. Schwartz, M.D.Troy, United StatesNo longer taking part
- Vital Prospects Clinical Research Institute, P.C.Tulsa, United StatesNo longer taking part
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT03899259
- Record updated
- 7 April 2026
- Original description
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
Inclusion: Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent; 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 SALT (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. Note: participants who have severe or very 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; 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.