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A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Eli Lilly and Company Foundation
 
Acronym KP IRB No.
BRAVE-AA2 1416289
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals histologically confirmed with Severe or Very Severe Alopecia Areata
 
Purpose
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
 
Detailed Description
Percentage of Participants Achieving Alopecia Areata Investigator Global Assessment (AA-IGA™) 0 or 1 with a >/=2 Point Improvement. Time Frame: Week 36. Percentage of participants achieving AA-IGA™ 0 or 1 with a >/=2 point improvement.
 
Gender Age Limit
Male & Female 18 - 70 years
 
Inclusion Criteria
  • Are at least 18 years and
  • Have severe or very severe AA, as determined by all of the following: (a) 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, (b) No spontaneous improvement over the past 6 months, (c) 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)

 
Keywords and/or Specific Medical Conditions
  • Alopecia
  • Pathological Conditions, Anatomical
  • Alopecia Areata
  • Skin Diseases
  • Hair Diseases
  • Dermatology
  • Hypotrichosis
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Dermatology


Principal Investigator:
Paradi Mirmirani, MD
Contact Information:
- Susan Campbell
-susan.campbell@kp.org
-San Francisco Medical Center


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