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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Key facts

Study ID

NCT03899259

Run by

Eli Lilly and Company

People needed

606

Starts

2019-07-08

Expected to finish

2024-11-19

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Primarily "diffuse" type of AA.
• 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).

Where it is running

• Investigate MD — Scottsdale, Arizona, United States
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• Quest Dermatology Research — Northridge, California, United States
• Kaiser Permanente Hospital — San Francisco, California, United States
• New England Research Associates — Bridgeport, Connecticut, United States
• Florida Academic Centers Research and Education, LLC — Coral Gables, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The South Bend Clinic Center for Research — South Bend, Indiana, United States
• Qualmedica Research, LLC — Owensboro, Kentucky, United States
• Dermatology and Skin Cancer Specialists — Rockville, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Associated Skin Care Specialists — New Brighton, Minnesota, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Joseph J. Schwartz, M.D. — Troy, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Dermatology Specialists of Charlotte — Charlotte, North Carolina, United States
• M3-Emerging Medical Research — Raleigh, North Carolina, United States
• Bexley Dermatology Research — Bexley, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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