Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
  • Drug: Placebo
    Administered orally.
Experimental
Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
  • Drug: Placebo
    Administered orally.
Placebo Comparator
Placebo
Placebo administered orally.
  • Drug: Placebo
    Administered orally.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467-2490
Contact:
7189202176

More Details

NCT ID
NCT03570749
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.