A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (NCT03899259) | Clinical Trial Compass
CompletedPhase 3
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
United States606 participantsStarted 2019-07-08
Plain-language summary
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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 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).
What they're measuring
1
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20