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The trial is taking place at:
S

Skin Care Physicians of Georgia | Macon, GA

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

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Lilly

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Alopecia Areata

Treatments

Drug: Baricitinib
Drug: Placebo

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

824 estimated 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

824 participants in 4 patient groups, including a placebo group

Baricitinib High Dose
Experimental group
Description:
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Treatment:
Drug: Placebo
Drug: Baricitinib
Baricitinib Low Dose
Experimental group
Description:
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Treatment:
Drug: Placebo
Drug: Baricitinib
Placebo
Placebo Comparator group
Description:
Participants administered orally.
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

Trial contacts and locations

75

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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