A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03899259

I4V-MC-JAIR (Other Identifier)

16978

Details and patient eligibility

About

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

Enrollment: 546 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.

• 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 (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. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 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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546 participants in 6 patient groups, including a placebo group

4 Milligram (mg) Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Baricitinib

2 mg Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

4 mg Baricitinib Maximum Extended Enrollment (MEE)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Baricitinib

2 mg Baricitinib MEE

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

Placebo MEE

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo