The trial is taking place at:
C

Clinical Research Puerto Rico | San Juan, PR

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

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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

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

Trial documents
2

Trial contacts and locations

98

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Data sourced from clinicaltrials.gov

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