A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)

Lilly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03570749

I4V-MC-JAHO (Other Identifier)

16582

Details and patient eligibility

About

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.

Enrollment: 784 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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784 participants in 16 patient groups, including a placebo group

Placebo Phase 2

Placebo Comparator group

Description:

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.

Treatment:

Drug: Baricitinib

Drug: Placebo

1 Milligram (mg) / 4 mg Baricitinib Phase 2

Experimental group

Description:

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.

Treatment:

Drug: Baricitinib

2 mg Baricitinib Phase 2

Experimental group

Description:

Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.

Treatment:

Drug: Baricitinib

4 mg Baricitinib Phase 2

Experimental group

Description:

Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.

Treatment:

Drug: Baricitinib

Placebo Phase 3

Placebo Comparator group

Description:

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.

Treatment:

Drug: Baricitinib

Drug: Placebo

2 mg Baricitinib Phase 3

Experimental group

Description:

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.

Treatment:

Drug: Baricitinib

4 mg Baricitinib Phase 3

Experimental group

Description:

Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.

Treatment:

Drug: Baricitinib

Placebo/ Placebo Phase 3

Placebo Comparator group

Description:

Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.

Treatment:

Drug: Placebo

Placebo/ 2 mg Baricitinib Phase 3

Experimental group

Description:

Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.

Treatment:

Drug: Baricitinib

Placebo/ 4 mg Baricitinib Phase 3

Experimental group

Description:

Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.

Treatment:

Drug: Baricitinib

2 mg Baricitinib /2 mg Baricitinib Phase 3

Experimental group

Description:

Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.

Treatment:

Drug: Baricitinib

2 mg Baricitinib /4 mg Baricitinib Phase 3

Experimental group

Description:

Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.

Treatment:

Drug: Baricitinib

2 mg Baricitinib / Placebo Phase 3

Experimental group

Description:

Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.

Treatment:

Drug: Placebo

4 mg Baricitinib / Placebo Phase 3

Experimental group

Description:

Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.

Treatment:

Drug: Placebo

4 mg Baricitinib /4 mg Baricitinib Phase 3

Experimental group

Description:

Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.

Treatment:

Drug: Baricitinib

4 mg Baricitinib Phase 3 Open-Label Addendum

Experimental group

Description:

Participants who received one 4 mg Baricitinib tablet administered orally QD.

Treatment:

Drug: Baricitinib