NCT03899259: BRAVE-AA2

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

Completed Phase 3 Results posted Last updated 7 April 2026

What this trial tests

Phase 3 trial testing Baricitinib in Alopecia Areata in 606 participants. Completed in 19 November 2024.

Timeline

8 July 2019

Primary endpoint
24 January 2021

19 November 2024

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	606
Start date	8 July 2019
Primary completion	24 January 2021
Estimated completion	19 November 2024
Sites	96 locations across Japan, Taiwan, Israel, South Korea, Argentina, Puerto Rico, Australia, China

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →
• Placebo

Conditions studied

• Alopecia Areata — all drugs for Alopecia Areata →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 70, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 Primary · Week 36

The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT s

Group	Value	95% CI
Placebo	2.6	1.0 – 6.4
2 mg Baricitinib	17.3	12.2 – 24.0
4 mg Baricitinib	32.5	26.8 – 38.7

Percent Change From Baseline in SALT Score at Week 36 Secondary · Baseline, Week 36

SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score ind

Group	Value	95% CI
Placebo	-2.96	± 2.723
2 mg Baricitinib	-28.21	± 2.770
4 mg Baricitinib	-47.45	± 2.229

Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) Secondary · Week 12

SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scori

Group	Value	95% CI
Placebo	2.6	1.0 – 6.4
2 mg Baricitinib	10.9	6.9 – 16.8
4 mg Baricitinib	23.5	18.5 – 29.3

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 Secondary · Week 36

PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).

Group	Value	95% CI
Placebo	4.0	1.8 – 8.4
2 mg Baricitinib	16.1	11.1 – 22.8
4 mg Baricitinib	34.4	28.4 – 41.0

Time for Participants to Achieve SALT ≤ 20 at Week 36. Secondary · Week 36

The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT s

Group	Value	95% CI
Placebo	NA	NA – NA
2 mg Baricitinib	NA	NA – NA
4 mg Baricitinib	NA	NA – NA

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) Secondary · Week 36

ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.

Group	Value	95% CI
Placebo	4.5	1.9 – 10.0
2 mg Baricitinib	11.5	6.7 – 19.1
4 mg Baricitinib	34.8	27.9 – 42.4

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) Secondary · Week 36

ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.

Group	Value	95% CI
Placebo	5.6	2.4 – 12.4
2 mg Baricitinib	10.1	5.4 – 18.1
4 mg Baricitinib	34.3	26.9 – 42.5

Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline) Secondary · Week 36

PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.

Group	Value	95% CI
Placebo	4.7	2.0 – 10.5
2 mg Baricitinib	14.8	9.3 – 22.7
4 mg Baricitinib	35.8	28.8 – 43.3

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) Secondary · Week 36

PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.

Group	Value	95% CI
Placebo	1.1	0.2 – 6.1
2 mg Baricitinib	18.9	12.1 – 28.2
4 mg Baricitinib	34.6	27.0 – 43.0

Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score Secondary · Baseline, Week 36

Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on qu

Group	Value	95% CI
Placebo	1.17	± 1.415
2 mg Baricitinib	-1.85	± 1.425
4 mg Baricitinib	-3.04	± 1.138

Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 Secondary · Baseline, Week 36

Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on qu

Group	Value	95% CI
Placebo	-11.98	± 2.154
2 mg Baricitinib	-18.73	± 2.171
4 mg Baricitinib	-25.40	± 1.732

Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 Secondary · Baseline, Week 36

Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on qu

Group	Value	95% CI
Placebo	-9.67	± 1.913
2 mg Baricitinib	-14.05	± 1.925
4 mg Baricitinib	-18.00	± 1.535

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 3/171 (2%)

Deaths: 0/171

2 mg Baricitinib

Serious: 5/173 (3%)

Deaths: 0/173

4 mg Baricitinib

Serious: 16/258 (6%)

Deaths: 0/258

All Baricitinib- Extended

Serious: 34/578 (6%)

Deaths: 0/578

Serious adverse events (35 terms)

Reaction	System	Placebo	2 mg Baricitinib	4 mg Baricitinib	All Baricitinib- Extended
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—
Covid-19 pneumonia	Infections and infestations	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Aortic valve incompetence	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Glaucoma	Eye disorders	—	—	—	—
Keratitis	Eye disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—
Strangulated umbilical hernia	Gastrointestinal disorders	—	—	—	—
Appendicitis perforated	Infections and infestations	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—	—	—
Lumbar vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—
Intraocular pressure increased	Investigations	—	—	—	—
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Endometrial cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Placebo	2 mg Baricitinib	4 mg Baricitinib	All Baricitinib- Extended
Covid-19	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Blood cholesterol increased	Investigations	—	—	—	—
Weight increased	Investigations	—	—	—	—

Most-reported serious reactions: Cholecystitis acute, Covid-19 pneumonia, Appendicitis, Pyelonephritis, Ankle fracture, Lymphadenopathy, Aortic valve incompetence, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT03899259 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Two Phase 3 Trials of Baricitinib for Alopecia Areata.
   King B, Ohyama M, Kwon O, Zlotogorski A, et al · · 2022 · cited 340× · PMID 35334197 · DOI 10.1056/nejmoa2110343
2. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
   Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
3. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
   Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
4. An overview of JAK/STAT pathways and JAK inhibition in alopecia areata.
   Lensing M, Jabbari A. · · 2022 · cited 100× · PMID 36110853 · DOI 10.3389/fimmu.2022.955035
5. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
   Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
6. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2).
   Kwon O, Senna MM, Sinclair R, Ito T, et al · · 2023 · cited 76× · PMID 36855020 · DOI 10.1007/s40257-023-00764-w
7. Inhibition of T-cell activity in alopecia areata: recent developments and new directions.
   Passeron T, King B, Seneschal J, Steinhoff M, et al · · 2023 · cited 54× · PMID 38022501 · DOI 10.3389/fimmu.2023.1243556
8. A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?
   Liu C, Kieltyka J, Fleischmann R, Gadina M, et al · · 2021 · cited 49× · PMID 34180156 · DOI 10.1002/art.41906