Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- 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 SALT Alopecia Areata 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 Criteria:
- 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).