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

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

  • Alopecia Areata

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
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 -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) 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
Placebo Comparator
Placebo Phase 2 		Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
  • Drug: Placebo
    Administered orally.
Experimental
1 Milligram (mg) / 4 mg Baricitinib Phase 2 		Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
2 mg Baricitinib Phase 2 		Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
4 mg Baricitinib Phase 2 		Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Placebo Comparator
Placebo Phase 3 		Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
  • Drug: Placebo
    Administered orally.
Experimental
2 mg Baricitinib Phase 3 		Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
4 mg Baricitinib Phase 3 		Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Placebo Comparator
Placebo/ Placebo Phase 3 		Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
  • Drug: Placebo
    Administered orally.
Experimental
Placebo/ 2 mg Baricitinib Phase 3 		Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
Placebo/ 4 mg Baricitinib Phase 3 		Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
2 mg Baricitinib /2 mg Baricitinib Phase 3 		Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
2 mg Baricitinib /4 mg Baricitinib Phase 3 		Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
2 mg Baricitinib / Placebo Phase 3 		Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
  • Drug: Placebo
    Administered orally.
Experimental
4 mg Baricitinib / Placebo Phase 3 		Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
  • Drug: Placebo
    Administered orally.
Experimental
4 mg Baricitinib /4 mg Baricitinib Phase 3 		Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104
Experimental
4 mg Baricitinib Phase 3 Open-Label Addendum 		Participants who received one 4 mg Baricitinib tablet administered orally QD.
  • Drug: Baricitinib
    Administered orally.
    Other names:
    • LY3009104

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact