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: 764 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 -- 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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764 participants in 8 patient groups, including a placebo group

4 Milligram (mg) Baricitinib Phase 2

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

Drug: Placebo

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

Drug: Placebo

1 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.

Treatment:

Drug: Baricitinib

Drug: Placebo

Placebo Phase 2

Placebo Comparator group

Description:

Participants received three placebo tablets administered orally QD to maintain the blind.

Treatment:

Drug: Placebo

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

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

Drug: Placebo

Placebo Phase 3

Placebo Comparator group

Description:

Participants received two placebo tablets administered orally QD.

Treatment:

Drug: Placebo

Open-Label Addenda Baricitinib High Dose

Experimental group

Description:

Baricitinib will be administered orally during the open-label addenda.

Treatment:

Drug: Baricitinib