A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
- Registration Number
- NCT03570749
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 784
-
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 SALT Alopecia Areata 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baricitinib High Dose Baricitinib Baricitinib administered orally. Placebo administered orally to maintain the blind. Baricitinib High Dose Placebo Baricitinib administered orally. Placebo administered orally to maintain the blind. Baricitinib Low Dose Baricitinib Baricitinib administered orally. Placebo administered orally to maintain the blind. Baricitinib Low Dose Placebo Baricitinib administered orally. Placebo administered orally to maintain the blind. Placebo Placebo Placebo administered orally. Open-Label Addenda Baricitinib High Dose Baricitinib Baricitinib will be administered orally during the open-label addenda.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 Week 36 Percentage of Participants Achieving SALT ≤ 20
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving 50% Improvement of SALT (SALT50) Week 12 Percentage of participants achieving SALT50
Percent Change from Baseline in SALT Score Baseline, Week 36 Percent change from baseline in SALT score
Time for Participants to Achieve SALT ≤ 20 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) 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 PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with Patient Reported Outcome (PRO) Measure for EB ≥2 at Baseline) 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) 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)
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score Week 36 Mean Change From Baseline in HADS Anxiety Score
Mean Change From Baseline in HADS Depression Score Week 36 Mean Change From Baseline in HADS Depression Score
Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline) 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)
Trial Locations
- Locations (75)
Hamamatsu University School of Medicine, University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Coastal Clinical Research, Inc
🇺🇸Mobile, Alabama, United States
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Tilda Research
🇺🇸Irvine, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Stanford Medicine Outpatient Center
🇺🇸Redwood City, California, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
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