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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. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

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. - 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).

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 		Participants administered orally.
  • Drug: Placebo
    Administered orally.
Experimental
Open-Label Addenda Baricitinib High Dose 		Baricitinib will be administered orally during the open-label addenda.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact

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.