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 - Phase 3Primary· 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 Phase 3
5.3
2.9 – 9.5
2 mg Baricitinib Phase 3
21.7
16.4 – 28.2
4 mg Baricitinib Phase 3
35.2
29.9 – 41.0
Percent Change From Baseline in SALT Score - Phase 3 Open-Label AddendumPrimary· Baseline, Week 52
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
4 mg Baricitinib Phase 3 Open-Label Addendum
-40.44
± 33.182
Percent Change From Baseline in SALT Score - Phase 3Secondary· Baseline, 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 Phase 3
-8.13
± 3.100
2 mg Baricitinib Phase 3
-31.23
± 3.157
4 mg Baricitinib Phase 3
-45.79
± 2.663
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3Secondary· 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 Phase 3
4.8
2.5 – 8.8
2 mg Baricitinib Phase 3
9.8
6.3 – 14.9
4 mg Baricitinib Phase 3
21.7
17.3 – 26.9
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3Secondary· 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 Phase 3
NA
NA – NA
2 mg Baricitinib Phase 3
NA
NA – NA
4 mg Baricitinib Phase 3
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) - Phase 3Secondary· 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 Phase 3
3.2
1.3 – 8.0
2 mg Baricitinib Phase 3
19.1
13.4 – 26.5
4 mg Baricitinib Phase 3
31.4
25.2 – 38.3
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) - Phase 3Secondary· 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 Phase 3
3.1
1.1 – 8.8
2 mg Baricitinib Phase 3
13.5
8.4 – 21.1
4 mg Baricitinib Phase 3
33.5
26.8 – 41.0
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 - Phase 3Secondary· Week 36
PRO is an assessment of the participant'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 Phase 3
5.0
2.6 – 9.2
2 mg Baricitinib Phase 3
16.0
11.3 – 22.2
4 mg Baricitinib Phase 3
33.1
27.8 – 38.9
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) - Phase 3Secondary· 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 Phase 3
3.1
1.2 – 7.6
2 mg Baricitinib Phase 3
16.3
11.1 – 23.3
4 mg Baricitinib Phase 3
32.1
25.7 – 39.1
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) - Phase 3Secondary· 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 Phase 3
2.0
0.6 – 7.0
2 mg Baricitinib Phase 3
19.6
13.3 – 28.0
4 mg Baricitinib Phase 3
29.8
23.3 – 37.3
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3Secondary· Baseline, Week 36
The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and ba
Group
Value
95% CI
Placebo Phase 3
-0.40
± 0.234
2 mg Baricitinib Phase 3
-1.22
± 0.236
4 mg Baricitinib Phase 3
-0.93
± 0.199
Mean Change From Baseline in HADS Depression Score - Phase 3Secondary· Baseline, Week 36
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Group
Value
95% CI
Placebo Phase 3
0.04
± 0.210
2 mg Baricitinib Phase 3
-0.38
± 0.213
4 mg Baricitinib Phase 3
-0.28
± 0.179
Adverse events — posted to ClinicalTrials.gov
Time frame: Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo Phase 2
Serious: 0/28 (0%)
Deaths: 0/28
2 mg Baricitinib Phase 2
Serious: 0/27 (0%)
Deaths: 0/27
4 mg Baricitinib Phase 2
Serious: 2/27 (7%)
Deaths: 0/27
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
Serious: 3/106 (3%)
Deaths: 0/106
Placebo Phase 3
Serious: 3/189 (2%)
Deaths: 0/189
2 mg Baricitinib Phase 3
Serious: 7/183 (4%)
Deaths: 0/183
4 mg Baricitinib Phase 3
Serious: 16/280 (6%)
Deaths: 0/280
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07543458 — Therapeutics for Moderate and Severe Dengue
· Phase 3
· not yet recruiting
NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra
· Phase 2
· not yet recruiting
NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia
· Phase 1, PHASE2
· not yet recruiting
NCT07268534 — Biologics in Folliculitis Decalvans : an Adaptative Trial Research
· Phase 2
· not yet recruiting
NCT06923072 — Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement
· Phase 2
· recruiting
Other recruiting trials for Alopecia Areata
Currently open trials in the same condition.
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· recruiting
NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata
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· recruiting
NCT07250997 — PALLAS Laser for Skin Diseases
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NCT07205159 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
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· recruiting
NCT06747611 — Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
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· recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
· Phase 2
· not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
· Phase 2
· not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants
· Phase 1
· completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
· Phase 1
· completed
NCT07030127 — A Study of LY3985863 in Healthy Participants
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03570749.