Phase 3
N=606
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03899259 ↗Enrolled (actual)
606
Serious AEs
4.9%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 — 2.6; 17.3; 32.5 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
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 |
2.6; 17.3; 32.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in SALT Score at Week 36 |
-2.96; -28.21; -47.45 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) |
2.6; 10.9; 23.5 | 0.005 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 |
4.0; 16.1; 34.4 | 0.001 sig |
| SECONDARY Time for Participants to Achieve SALT ≤ 20 at Week 36. |
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) |
4.5; 11.5; 34.8 | 0.076 |
| 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) |
5.6; 10.1; 34.3 | 0.260 |
| SECONDARY 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) |
4.7; 14.8; 35.8 | 0.017 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) |
1.1; 18.9; 34.6 | 0.002 sig |
| SECONDARY Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score |
1.17; -1.85; -3.04 | 0.129 |
| SECONDARY Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 |
-11.98; -18.73; -25.40 | 0.026 sig |
| SECONDARY Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 |
-9.67; -14.05; -18.00 | 0.103 |
| SECONDARY Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 |
-0.47; -0.67; -1.19 | 0.518 |
| SECONDARY Mean Change From Baseline in HADS Depression Score at Week 36 |
0.29; -0.22; -0.39 | 0.083 |
Summary
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
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.
- 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).
Data sourced from ClinicalTrials.gov (NCT03899259). 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.