Phase 3
N=110
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03570749 ↗Enrolled (actual)
110
Serious AEs
4.9%
Results posted
Oct 2025
Primary outcome: Primary: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 — 5.3; 21.7; 35.2 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Baricitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 |
5.3; 21.7; 35.2 | <0.001 sig |
| PRIMARY Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum |
-40.44 | — |
| SECONDARY Percent Change From Baseline in SALT Score - Phase 3 |
-8.13; -31.23; -45.79 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 |
4.8; 9.8; 21.7 | 0.047 sig |
| SECONDARY Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3 |
NA; NA; NA | — |
| SECONDARY 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 3 |
3.2; 19.1; 31.4 | <0.001 sig |
| SECONDARY 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 3 |
3.1; 13.5; 33.5 | 0.012 sig |
| SECONDARY 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 3 |
5.0; 16.0; 33.1 | <0.001 sig |
| SECONDARY 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 3 |
3.1; 16.3; 32.1 | 0.001 sig |
| SECONDARY 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 3 |
2.0; 19.6; 29.8 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 |
-0.40; -1.22; -0.93 | 0.005 sig |
| SECONDARY Mean Change From Baseline in HADS Depression Score - Phase 3 |
0.04; -0.38; -0.28 | 0.107 |
| SECONDARY Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum |
18.2 | — |
| SECONDARY Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum |
45.5 | — |
| SECONDARY Percentage of Participants Achieving 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 3 Open-Label Addendum |
50.0 | — |
| SECONDARY 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 3 Open-Label Addendum |
66.7 | — |
| SECONDARY 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 3 Open-Label Addendum |
20.0 | — |
Summary
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.
Eligibility Criteria
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 -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) 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).
Data sourced from ClinicalTrials.gov (NCT03570749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.