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

Conditions

• Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Key Dates

Start date

Jul 8, 2019

Status verified

Mar 2026

Primary completion

Jan 24, 2021

Completion

Nov 19, 2024

Study Design

Enrollment

606 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received two placebo tablets matched to baricitinib, administered orally once daily (QD) to maintain the blind.
• Experimental: 2 mg Baricitinib
  Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
• Experimental: 4 mg Baricitinib
  Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
• Placebo Comparator: Placebo/ Placebo
  Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
• Experimental: Placebo/ 2-mg Baricitinib
  Participants who received two placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
• Experimental: Placebo/ 4-mg Baricitinib
  Participants who received two placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
• Experimental: 2-mg Baricitinib/ 2-mg Baricitinib
  Participants who received 2 mg Baricitinib at Period 1 continued to receive same 2 mg Baricitinib dose administered orally QD in Period 2.
• Experimental: 2-mg Baricitinib/ 4-mg Baricitinib
  Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
• Experimental: 4-mg Baricitinib/ Placebo
  Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
• Experimental: 4-mg Baricitinib/ 2-mg Baricitinib
  Participants who received 4 mg Baricitinib at Period 1 switched to receive 2 mg Baricitinib administered orally QD in Period 2.
• Experimental: 4-mg Baricitinib/ 4-mg Baricitinib
  Participants who received 4 mg Baricitinib at Period 1 continued to receive same 4 mg Baricitinib administered orally QD in Period 2.

Primary Outcome Measure

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]

Locations (33)

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