A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03899259 |
Recruitment Status :
Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : January 26, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Areata | Drug: Baricitinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 546 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata |
Actual Study Start Date : | July 8, 2019 |
Actual Primary Completion Date : | January 24, 2021 |
Estimated Study Completion Date : | May 27, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
|
Drug: Baricitinib
Administered orally
Other Name: LY3009104 Drug: Placebo Administered orally |
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
|
Drug: Baricitinib
Administered orally
Other Name: LY3009104 Drug: Placebo Administered orally |
Placebo Comparator: Placebo
Placebo administered orally.
|
Drug: Placebo
Administered orally |
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]Percentage of Participants Achieving SALT ≤ 20
- Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 36 ]Percent change from baseline in SALT score
- Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 12 ]Percentage of participants achieving SALT50
- Percentage of Participants with Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 with a ≥2-point Improvement from Baseline Among Participants with a Score of ≥3 at Baseline [ Time Frame: Week 36 ]Percentage of participants with PRO for scalp hair assessment score of 0 or 1 with a ≥2-point Improvement from Baseline Among Participants with a Score of ≥3 at Baseline
- Time for Participants to Achieve SALT ≤ 20 [ Time Frame: Baseline through Week 36 ]Time for Participants to Achieve SALT ≤ 20
- Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)
- Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
- Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline) [ Time Frame: Week 36 ]Percentage of participants achieving PRO measure for EB 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline)
- Percentage of Participants Achieving PRO Measure for EL 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure EL ≥2 at Baseline) [ Time Frame: Week 36 ]Percentage of participants achieving PRO measure for EL 0 or 1 with ≥2-point Improvement from Baseline (Among Participants with PRO Measure EL ≥2 at Baseline)
- Change from Baseline in Skindex-16 AA Symptoms Domain Score [ Time Frame: Baseline, Week 36 ]Change from Baseline in Skindex-16 AA Symptoms Domain Score
- Change from Baseline in Skindex-16 AA Emotions Domain Score [ Time Frame: Baseline, Week 36 ]Change from Baseline in Skindex-16 AA Emotions Domain Score
- Change from Baseline in Skindex-16 AA Functioning Domain Score [ Time Frame: Baseline, Week 36 ]Change from Baseline in Skindex-16 AA Functioning Domain Score
- Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score [ Time Frame: Week 36 ]Mean Change From Baseline in HADS Anxiety Score
- Mean Change From Baseline in HADS Depression Score [ Time Frame: Week 36 ]Mean Change From Baseline in HADS Depression Score

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899259

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03899259 |
Other Study ID Numbers: |
16978 I4V-MC-JAIR ( Other Identifier: Eli Lilly and Company ) |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | January 26, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |