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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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.

Key facts

Study ID

NCT03570749

Run by

Eli Lilly and Company

People needed

784

Starts

2018-09-24

Expected to finish

2025-01-29

Last updated by the study team

2026-04-16

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.
• 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.

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

• Coastal Clinical Research, Inc — Mobile, Alabama, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Alliance Research Centers — Irvine, California, United States
• University of CA, Irvine — Irvine, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Stanford Health Care — Redwood City, California, United States
• University of California Davis-Dermatology — Sacramento, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Mosaic Dermatology — Santa Monica, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Skin Care Physicians of Georgia — Macon, Georgia, United States
• Medaphase Inc — Newnan, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Forefront Research — Louisville, Kentucky, United States
• Callender Center for Clinical Research, LLC / Research — Glenn Dale, Maryland, United States
• ActivMed Practices and Research — Beverly, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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