A Study of Baricitinib (LY3009104) in Participants 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

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.

Key Dates

Start date

Sep 24, 2018

Status verified

Mar 2026

Primary completion

Feb 2, 2021

Completion

Jan 29, 2025

Study Design

Enrollment

784 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Experimental: 4 mg Baricitinib Phase 3 Open-Label Addendum
  Participants who received one 4 mg Baricitinib tablet administered orally QD.

Primary Outcome Measure

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 [ Time Frame: Week 36 ]

Locations (50)

Find similar trials in Birmingham, AL

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