Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Eli Lilly and Company

Collaborator: Incyte Corporation

Stanford Investigator(s):

Intervention(s):

  • Drug: Baricitinib
  • Drug: Placebo

Phase:

Phase 2/Phase 3

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.

   - 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).

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting