Trial Outcomes & Findings for ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis (NCT NCT03594227)

Last Updated: 2020-09-16

Results Overview

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

Baseline-Week 24

Results posted on

2020-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	ATI-501 400mg BID Dosing ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose	ATI-501 600mg BID Dosing ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose	ATI-501 800mg BID Dosing ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration	Placebo Placebo: BID - oral administration
Overall Study STARTED	23	23	22	19
Overall Study COMPLETED	18	19	19	14
Overall Study NOT COMPLETED	5	4	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ATI-501 400mg BID Dosing ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose	ATI-501 600mg BID Dosing ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose	ATI-501 800mg BID Dosing ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration	Placebo Placebo: BID - oral administration
Overall Study Adverse Event	2	1	0	2
Overall Study Lost to Follow-up	1	1	1	0
Overall Study Withdrawal by Subject	1	1	1	1
Overall Study Pregnancy	0	1	0	0
Overall Study Sponsor Decision	0	0	0	1
Overall Study Programmatic Analysis Non-completer	1	0	1	1

Baseline Characteristics

Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo: BID - oral administration	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=87 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=23 Participants	21 Participants n=23 Participants	22 Participants n=22 Participants	16 Participants n=19 Participants	81 Participants n=87 Participants
Age, Categorical >=65 years	1 Participants n=23 Participants	2 Participants n=23 Participants	0 Participants n=22 Participants	3 Participants n=19 Participants	6 Participants n=87 Participants
Age, Continuous	38.7 years STANDARD_DEVIATION 12.99 • n=23 Participants	40.4 years STANDARD_DEVIATION 13.56 • n=23 Participants	40.5 years STANDARD_DEVIATION 12.44 • n=22 Participants	41.8 years STANDARD_DEVIATION 16.01 • n=19 Participants	40.3 years STANDARD_DEVIATION 13.52 • n=87 Participants
Sex: Female, Male Female	17 Participants n=23 Participants	12 Participants n=23 Participants	13 Participants n=22 Participants	14 Participants n=19 Participants	56 Participants n=87 Participants
Sex: Female, Male Male	6 Participants n=23 Participants	11 Participants n=23 Participants	9 Participants n=22 Participants	5 Participants n=19 Participants	31 Participants n=87 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=17 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	3 Participants n=19 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	2 Participants n=16 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	3 Participants n=15 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	15 Participants n=67 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=17 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	15 Participants n=19 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	13 Participants n=16 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	12 Participants n=15 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	50 Participants n=67 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=17 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	1 Participants n=19 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	1 Participants n=16 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	0 Participants n=15 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.	2 Participants n=67 Participants • Ethnicity was only sought for those subjects self-identifying as "White" when reporting their Race.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	1 Participants n=87 Participants
Race (NIH/OMB) Asian	0 Participants n=23 Participants	0 Participants n=23 Participants	1 Participants n=22 Participants	1 Participants n=19 Participants	2 Participants n=87 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=87 Participants
Race (NIH/OMB) Black or African American	6 Participants n=23 Participants	3 Participants n=23 Participants	5 Participants n=22 Participants	3 Participants n=19 Participants	17 Participants n=87 Participants
Race (NIH/OMB) White	17 Participants n=23 Participants	19 Participants n=23 Participants	16 Participants n=22 Participants	15 Participants n=19 Participants	67 Participants n=87 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=87 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=87 Participants
Fitzpatrick Skin Type I - Always Burns	0 Participants n=23 Participants	0 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=19 Participants	2 Participants n=87 Participants
Fitzpatrick Skin Type II - Burns Easily	5 Participants n=23 Participants	7 Participants n=23 Participants	6 Participants n=22 Participants	8 Participants n=19 Participants	26 Participants n=87 Participants
Fitzpatrick Skin Type III - Burns Moderately	7 Participants n=23 Participants	9 Participants n=23 Participants	4 Participants n=22 Participants	8 Participants n=19 Participants	28 Participants n=87 Participants
Fitzpatrick Skin Type IV - Burns Minimally	6 Participants n=23 Participants	3 Participants n=23 Participants	4 Participants n=22 Participants	0 Participants n=19 Participants	13 Participants n=87 Participants
Fitzpatrick Skin Type V - Rarely Burns	3 Participants n=23 Participants	4 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=19 Participants	14 Participants n=87 Participants
Fitzpatrick Skin Type VI - Never Burns	2 Participants n=23 Participants	0 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=19 Participants	4 Participants n=87 Participants
Hair Pull Test - Dislodged Hairs Normal (≤2 hairs dislodged)	11 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	9 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	7 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	6 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	33 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair Pull Test - Dislodged Hairs Abnormal (>2 hairs dislodged)	0 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	5 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	1 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	1 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	7 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair Pull Test - Dislodged Hairs N/A for subjects with AU and AT (>95% hair loss)	12 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	9 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	13 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	11 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	45 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair pull test - broken hairs No	11 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	12 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	6 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	6 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	35 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair pull test - broken hairs Yes	0 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	2 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	2 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	1 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	5 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair pull test - broken hairs N/A for subjects with AU and AT (>95% hair loss)	12 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	9 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	13 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	11 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	45 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair Pull Test - Broken at Borders No	11 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	12 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	6 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	6 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	35 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair Pull Test - Broken at Borders Yes	0 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	2 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	2 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	1 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	5 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Hair Pull Test - Broken at Borders N/A for subjects with AU and AT (>95% hair loss)	12 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	9 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	13 Participants n=21 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	11 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	45 Participants n=85 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Vellus Hair Present No	20 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	18 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	18 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	15 Participants n=19 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	71 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Vellus Hair Present Yes	3 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	4 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	4 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	4 Participants n=19 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	15 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Indeterminate hair present No	21 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	19 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	19 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	16 Participants n=19 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	75 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Indeterminate hair present Yes	2 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	3 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	3 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	3 Participants n=19 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	11 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Baseline Severity of Alopecia Tool (SALT) Score Mean	78 score on a scale STANDARD_DEVIATION 26.7 • n=23 Participants	76 score on a scale STANDARD_DEVIATION 23.4 • n=23 Participants	81 score on a scale STANDARD_DEVIATION 25.8 • n=22 Participants	85 score on a scale STANDARD_DEVIATION 24.8 • n=19 Participants	80 score on a scale STANDARD_DEVIATION 25.0 • n=87 Participants
Baseline Severity of Alopecia Tool (SALT) Scores Percentiles <50%	5 Participants n=23 Participants	2 Participants n=23 Participants	5 Participants n=22 Participants	3 Participants n=19 Participants	15 Participants n=87 Participants
Baseline Severity of Alopecia Tool (SALT) Scores Percentiles ≥50%	18 Participants n=23 Participants	21 Participants n=23 Participants	17 Participants n=22 Participants	16 Participants n=19 Participants	72 Participants n=87 Participants
Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only Some hair	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=19 Participants	1 Participants n=87 Participants
Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only A little hair	8 Participants n=23 Participants	8 Participants n=23 Participants	5 Participants n=22 Participants	4 Participants n=19 Participants	25 Participants n=87 Participants
Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only No hair	3 Participants n=23 Participants	6 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=19 Participants	16 Participants n=87 Participants
Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only N/A for subjects with AU and AT (>95% hair loss)	12 Participants n=23 Participants	9 Participants n=23 Participants	13 Participants n=22 Participants	11 Participants n=19 Participants	45 Participants n=87 Participants
Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp Most hair	1 Participants n=23 Participants	1 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=19 Participants	4 Participants n=87 Participants
Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp Some hair	5 Participants n=23 Participants	6 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=19 Participants	18 Participants n=87 Participants
Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp A little hair	6 Participants n=23 Participants	7 Participants n=23 Participants	6 Participants n=22 Participants	8 Participants n=19 Participants	27 Participants n=87 Participants
Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp No hair	11 Participants n=23 Participants	9 Participants n=23 Participants	10 Participants n=22 Participants	8 Participants n=19 Participants	38 Participants n=87 Participants
Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only A little hair	6 Participants n=23 Participants	7 Participants n=23 Participants	5 Participants n=22 Participants	5 Participants n=19 Participants	23 Participants n=87 Participants
Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only No hair	5 Participants n=23 Participants	7 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=19 Participants	19 Participants n=87 Participants
Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only N/A for subjects with AU and AT (>95% hair loss)	12 Participants n=23 Participants	9 Participants n=23 Participants	13 Participants n=22 Participants	11 Participants n=19 Participants	45 Participants n=87 Participants
Baseline scalp-ClinRO for entire scalp Some hair	8 Participants n=23 Participants	8 Participants n=23 Participants	6 Participants n=22 Participants	2 Participants n=19 Participants	24 Participants n=87 Participants
Baseline scalp-ClinRO for entire scalp A little hair	4 Participants n=23 Participants	7 Participants n=23 Participants	7 Participants n=22 Participants	9 Participants n=19 Participants	27 Participants n=87 Participants
Baseline scalp-ClinRO for entire scalp No hair	11 Participants n=23 Participants	8 Participants n=23 Participants	9 Participants n=22 Participants	8 Participants n=19 Participants	36 Participants n=87 Participants
Previous Therapies for Alopecia Subjects using prior therapy for alopecia	21 Participants n=23 Participants	18 Participants n=23 Participants	21 Participants n=22 Participants	16 Participants n=19 Participants	76 Participants n=87 Participants
Previous Therapies for Alopecia Topical immunotherapy	8 Participants n=23 Participants	3 Participants n=23 Participants	5 Participants n=22 Participants	3 Participants n=19 Participants	19 Participants n=87 Participants
Previous Therapies for Alopecia Corticosteroids	16 Participants n=23 Participants	13 Participants n=23 Participants	15 Participants n=22 Participants	10 Participants n=19 Participants	54 Participants n=87 Participants
Previous Therapies for Alopecia Systemic steroids	11 Participants n=23 Participants	11 Participants n=23 Participants	5 Participants n=22 Participants	7 Participants n=19 Participants	34 Participants n=87 Participants
Previous Therapies for Alopecia DMARDS	0 Participants n=23 Participants	1 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=19 Participants	2 Participants n=87 Participants
Previous Therapies for Alopecia Biologics or immunosuppressants	0 Participants n=23 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=19 Participants	2 Participants n=87 Participants
Previous Therapies for Alopecia Plaquenil	1 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=19 Participants	2 Participants n=87 Participants
Previous Therapies for Alopecia Phototherapy	1 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	1 Participants n=87 Participants
Previous Therapies for Alopecia Laser therapy	1 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=19 Participants	2 Participants n=87 Participants
Previous Therapies for Alopecia NB UVB	0 Participants n=23 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	1 Participants n=87 Participants
Previous Therapies for Alopecia Other	3 Participants n=23 Participants	2 Participants n=23 Participants	6 Participants n=22 Participants	3 Participants n=19 Participants	14 Participants n=87 Participants
Diagnosis Type Alopecia Areata	11 Participants n=23 Participants	14 Participants n=23 Participants	9 Participants n=22 Participants	9 Participants n=19 Participants	43 Participants n=87 Participants
Diagnosis Type Alopecia Universalis	4 Participants n=23 Participants	5 Participants n=23 Participants	7 Participants n=22 Participants	5 Participants n=19 Participants	21 Participants n=87 Participants
Diagnosis Type Alopecia Totalis	8 Participants n=23 Participants	4 Participants n=23 Participants	6 Participants n=22 Participants	5 Participants n=19 Participants	23 Participants n=87 Participants
Ophiasis pattern of hair loss No ophiasis pattern	19 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	19 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	18 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	17 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	73 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Ophiasis pattern of hair loss Ophiasis and Alopecia Areata	4 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	4 Participants n=23 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	4 Participants n=22 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	1 Participants n=18 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.	13 Participants n=86 Participants • The difference in the number analyzed in row differs from overall is occurring due to expected data points being omitted from collection due to site error.
Duration of alopecia (years)	13.7 years STANDARD_DEVIATION 11.01 • n=23 Participants	9.5 years STANDARD_DEVIATION 9.78 • n=23 Participants	10.7 years STANDARD_DEVIATION 11.36 • n=22 Participants	11.3 years STANDARD_DEVIATION 12.04 • n=19 Participants	11.3 years STANDARD_DEVIATION 10.94 • n=87 Participants
Duration of current episode of alopecia (weeks)	224.2 weeks STANDARD_DEVIATION 184.63 • n=23 Participants	189.5 weeks STANDARD_DEVIATION 148.31 • n=23 Participants	176.3 weeks STANDARD_DEVIATION 162.50 • n=22 Participants	253.2 weeks STANDARD_DEVIATION 153.59 • n=19 Participants	209.3 weeks STANDARD_DEVIATION 163.10 • n=87 Participants

PRIMARY outcome

Timeframe: Baseline-Week 24

Population: This primary analysis utilized the SALT score with imputation for last observation carried forward (LOCF) and was based on the intent-to-treat population.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24	-25.6 percent Standard Deviation 39.75	-30.4 percent Standard Deviation 41.23	-25.9 percent Standard Deviation 29.86	-6.3 percent Standard Deviation 23.36

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24	-26.88 percent Standard Error 5.165	-32.24 percent Standard Error 5.165	-26.87 percent Standard Error 5.281	-7.70 percent Standard Error 5.683

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24	-14.6 score on a scale Standard Deviation 23.67	-18.6 score on a scale Standard Deviation 27.29	-20.9 score on a scale Standard Deviation 26.50	-3.3 score on a scale Standard Deviation 8.21

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24	-17.6 score on a scale Standard Deviation 26.93	-22.2 score on a scale Standard Deviation 28.99	-20.7 score on a scale Standard Deviation 25.04	-3.2 score on a scale Standard Deviation 8.42

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24	6 Participants	7 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Count of Subjects in Each Treatment Arm Achieving at Least a 50% Reduction in Severity of Alopecia Tool (SALT) Score at Week 24 Compared to Baseline	6 Participants	7 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area \[1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)\]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Better by 4 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Better by 3 points	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Better by 2 points	0 Participants	2 Participants	2 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Better by 1 point	4 Participants	5 Participants	6 Participants	3 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow No change	15 Participants	15 Participants	10 Participants	13 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Worse by 1 point	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Worse by 2 points	2 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Better by 4 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Better by 3 points	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Better by 2 points	0 Participants	0 Participants	3 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Better by 1 point	3 Participants	6 Participants	4 Participants	4 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow No change	17 Participants	12 Participants	12 Participants	13 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Worse by 1 point	1 Participants	4 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow Worse by 2 points	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Better by 4 points	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Better by 3 points	1 Participants	0 Participants	2 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Better by 2 points	1 Participants	1 Participants	3 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Better by 1 point	3 Participants	3 Participants	3 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash No Change	15 Participants	15 Participants	12 Participants	16 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Worse by 1 point	0 Participants	3 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Worse by 2 points	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash Worse by 3 points	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Better by 4 points	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Better by 3 points	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Better by 2 points	1 Participants	1 Participants	3 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Better by 1 point	3 Participants	4 Participants	4 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash No Change	16 Participants	16 Participants	13 Participants	16 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Worse by 1 point	0 Participants	1 Participants	0 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Worse by 3 points	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=6 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=11 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=5 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Better by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Better by 1 point	2 Participants	1 Participants	0 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Better by 3 points	0 Participants	1 Participants	3 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Better by 2 points	0 Participants	0 Participants	3 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects No Change	4 Participants	6 Participants	2 Participants	3 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Worse by 1 point	0 Participants	2 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects Worse by 2 points	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area \[1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)\]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Better by 3 points	1 Participants	0 Participants	2 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Better by 2 points	4 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow No Change	16 Participants	14 Participants	10 Participants	13 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Better by 1 points	1 Participants	5 Participants	8 Participants	3 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Worse by 1 point	1 Participants	3 Participants	1 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Better by 1 point	3 Participants	5 Participants	7 Participants	4 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow No Change	16 Participants	13 Participants	10 Participants	12 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Better by 3 points	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Better by 2 points	2 Participants	2 Participants	2 Participants	1 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Worse by 1 point	0 Participants	2 Participants	1 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Worse by 2 points	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Better by 4 points	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Better by 3 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Better by 2 points	2 Participants	1 Participants	2 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Better by 1 point	7 Participants	3 Participants	4 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash No Change	13 Participants	16 Participants	12 Participants	15 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Worse by 1 point	0 Participants	1 Participants	1 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Worse by 2 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Better by 4 points	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Worse by 3 points	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Better by 3 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Better by 2 points	2 Participants	2 Participants	2 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Better by 1 point	6 Participants	1 Participants	2 Participants	3 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash No Change	13 Participants	15 Participants	14 Participants	14 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Worse by 1 point	0 Participants	3 Participants	2 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash Worse by 2 points	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=6 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=11 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=5 Participants Placebo - oral administration
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Better by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Better by 2 points	0 Participants	1 Participants	3 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Better by 1 point	2 Participants	3 Participants	3 Participants	2 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects No Change	4 Participants	5 Participants	2 Participants	3 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Worse by 1 point	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=14 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=9 Participants Placebo - oral administration
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata No change	3 Participants	5 Participants	3 Participants	4 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Worse by 1 point	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Worse by 2 points	2 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Better by 3 points	2 Participants	2 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Better by 2 points	3 Participants	2 Participants	2 Participants	1 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Better by 1 point	1 Participants	3 Participants	3 Participants	3 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data. One patient was excluded from the analysis based on the visit windowing conventions that was previously established. This patient's Week 24 SGIS occurred at Day 128, which is outside of the window for inclusion of results at Week 24.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=9 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=13 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=10 Participants Placebo - oral administration
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 4 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 3 points	1 Participants	0 Participants	3 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis No change	6 Participants	6 Participants	4 Participants	8 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 1 point	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 2 points	2 Participants	1 Participants	2 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 1 point	2 Participants	0 Participants	3 Participants	2 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=14 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=9 Participants Placebo - oral administration
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Better by 3 points	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Better by 2 points	3 Participants	4 Participants	1 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Better by 1 point	1 Participants	3 Participants	2 Participants	3 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata No Change	5 Participants	4 Participants	6 Participants	4 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Worse by 1 point	1 Participants	2 Participants	0 Participants	2 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=12 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=9 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=13 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=10 Participants Placebo - oral administration
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 1 point	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 4 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 3 points	1 Participants	0 Participants	2 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 2 points	0 Participants	1 Participants	2 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis Better by 1 point	5 Participants	0 Participants	3 Participants	3 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis No change	6 Participants	7 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia (inclusive of all 3 subtypes observed on study) in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA has a recall period of "over the past seven days". An 11-point NRS with anchors "0 - Not at all \[impact\]" and "10 - Extremely \[impact\]" (e.g., "Not at all bothersome" and "Extremely bothersome"; "Not at all worried" and "Extremely worried") is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24	-1.9 score on a scale Standard Deviation 1.89	-1.8 score on a scale Standard Deviation 2.79	-1.2 score on a scale Standard Deviation 1.80	-1.1 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=10 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=11 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=8 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=8 Participants Placebo - oral administration
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata A little satisfied	0 Participants	0 Participants	0 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata Neither satisfied or dissatisfied	0 Participants	2 Participants	2 Participants	2 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata Extremely satisfied	5 Participants	5 Participants	2 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata Moderately satisfied	2 Participants	2 Participants	2 Participants	0 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata A little dissatisfied	1 Participants	0 Participants	0 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata Moderately dissatisfied	1 Participants	1 Participants	1 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata Extremely dissatisfied	1 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=12 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=9 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=13 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=10 Participants Placebo - oral administration
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis A little dissatisfied	1 Participants	0 Participants	0 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis Moderately dissatisfied	1 Participants	1 Participants	1 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis Extremely dissatisfied	1 Participants	1 Participants	2 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis Extremely satisfied	1 Participants	1 Participants	3 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis Moderately satisfied	3 Participants	1 Participants	5 Participants	2 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis A little satisfied	1 Participants	2 Participants	1 Participants	1 Participants
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis Neither satisfied or dissatisfied	4 Participants	3 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=14 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=7 Participants Placebo - oral administration
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 6 points	4 Participants	4 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 4 points	0 Participants	1 Participants	2 Participants	1 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 3 points	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 2 points	0 Participants	3 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 1 points	0 Participants	2 Participants	1 Participants	1 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata No change	4 Participants	4 Participants	2 Participants	4 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 1 point	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 2 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 5 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Worse by 6 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata Better by 5 points	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=12 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=9 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=13 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=10 Participants Placebo - oral administration
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 6 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 5 points	1 Participants	0 Participants	5 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 4 points	2 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 1 point	0 Participants	0 Participants	2 Participants	2 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 3 points	3 Participants	3 Participants	1 Participants	2 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Better by 2 points	0 Participants	2 Participants	0 Participants	1 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis No change	5 Participants	1 Participants	3 Participants	5 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 1 point	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 2 points	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 3 points	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 5 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis Worse by 6 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of "skin problem" and "skin" as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24	-1.5 score on a scale Standard Deviation 4.33	-5.3 score on a scale Standard Deviation 5.21	-1.7 score on a scale Standard Deviation 3.97	-1.7 score on a scale Standard Deviation 5.99

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward (LOCF) to address missing data. Per SAP, the allowed window days for Week 24 visit are 155-182. There were 4 patients in the 400mg group, 4 patients in the 600mg group, 3 patients in the 800mg group, and 5 patients in the placebo group who fell outside this window.

The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=19 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=19 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=19 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=14 Participants Placebo - oral administration
Subject Global Impression of Change (SGIC) at Week 24 Much worse	0 Participants	0 Participants	0 Participants	0 Participants
Subject Global Impression of Change (SGIC) at Week 24 Very much improved	5 Participants	6 Participants	2 Participants	1 Participants
Subject Global Impression of Change (SGIC) at Week 24 Much improved	3 Participants	1 Participants	7 Participants	1 Participants
Subject Global Impression of Change (SGIC) at Week 24 A little improved	4 Participants	5 Participants	6 Participants	6 Participants
Subject Global Impression of Change (SGIC) at Week 24 No change	7 Participants	7 Participants	3 Participants	6 Participants
Subject Global Impression of Change (SGIC) at Week 24 A little worse	0 Participants	0 Participants	1 Participants	0 Participants
Subject Global Impression of Change (SGIC) at Week 24 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=19 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=19 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=19 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=14 Participants Placebo - oral administration
Physician Global Impression of Change (PhGIC) at Week 24 A little worse	1 Participants	0 Participants	1 Participants	0 Participants
Physician Global Impression of Change (PhGIC) at Week 24 Much worse	0 Participants	0 Participants	0 Participants	0 Participants
Physician Global Impression of Change (PhGIC) at Week 24 Very much improved	5 Participants	7 Participants	3 Participants	2 Participants
Physician Global Impression of Change (PhGIC) at Week 24 Much improved	3 Participants	0 Participants	6 Participants	0 Participants
Physician Global Impression of Change (PhGIC) at Week 24 A little improved	2 Participants	5 Participants	5 Participants	5 Participants
Physician Global Impression of Change (PhGIC) at Week 24 No change	8 Participants	7 Participants	4 Participants	7 Participants
Physician Global Impression of Change (PhGIC) at Week 24 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment for Patchy Alopecia Areata (AAP) patients regarding the appearance of the patient's target patch (identified by the patient as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=14 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=8 Participants Placebo - oral administration
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 3 points	4 Participants	5 Participants	1 Participants	2 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 4 points	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 2 points	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 1 point	0 Participants	3 Participants	4 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata No change	6 Participants	2 Participants	2 Participants	5 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 1 point	0 Participants	2 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Scalp Clinician Reported Outcome for Entire Scalp was completed for patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's whole scalp. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Better by 2 points	3 Participants	2 Participants	3 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Better by 1 point	7 Participants	9 Participants	8 Participants	8 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Worse by 1 point	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Better by 3 points	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients No change	11 Participants	10 Participants	10 Participants	10 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Scalp Patient Reported Outcome for Target Patch was completed by patients with Patchy Alopecia Areata (AAP) and assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by AAP subjects at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=11 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=14 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=9 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=8 Participants Placebo - oral administration
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 4 points	2 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 3 points	3 Participants	4 Participants	1 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 2 points	1 Participants	3 Participants	0 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Better by 1 point	0 Participants	2 Participants	4 Participants	5 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata No change	4 Participants	1 Participants	2 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 1 point	1 Participants	3 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline-Week 24

Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.

The Scalp Patient Reported Outcome for Entire Scalp was completed by patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by patients at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Outcome measures
Measure	ATI-501 400mg BID Dosing n=23 Participants ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 Participants ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose	ATI-501 800mg BID Dosing n=22 Participants ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration	Placebo n=19 Participants Placebo - oral administration
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Better by 4 points	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Worse by 3 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Better by 2 points	4 Participants	2 Participants	5 Participants	1 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Better by 3 points	2 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Better by 1 point	5 Participants	10 Participants	7 Participants	7 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients No change	11 Participants	8 Participants	8 Participants	11 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Worse by 1 point	1 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Worse by 2 points	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients Worse by 4 points	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

ATI-501 400mg BID Dosing

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ATI-501 600mg BID Dosing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

ATI-501 800mg BID Dosing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Marco Cardillo, Clinical Trial Manager

Aclaris Therapeutics, Inc.

Phone: 484-540-6299

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	ATI-501 400mg BID Dosing n=23 participants at risk ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose	ATI-501 600mg BID Dosing n=23 participants at risk ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose	ATI-501 800mg BID Dosing n=22 participants at risk ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration	Placebo n=19 participants at risk Placebo: BID - oral administration
Gastrointestinal disorders Nausea	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Constipation	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Feces soft	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Gastroesophageal reflux disease	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Gastrointestinal disorders Vomiting	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
General disorders Fatigue	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Infections and infestations Folliculitis	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	5.3% 1/19 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Infections and infestations Vulvovaginal mycotic infection	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Investigations Alanine aminotransferase increased	8.7% 2/23 • Number of events 2 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Investigations Blood creatine phosphokinase increased	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	5.3% 1/19 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Investigations Aspartate aminotransferase increased	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Nervous system disorders Dizziness	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Nervous system disorders Headache	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Nervous system disorders Paraesthesia	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Renal and urinary disorders Chromaturia	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Reproductive system and breast disorders Adnexa uteri pain	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.3% 1/23 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	5.3% 1/19 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	4.5% 1/22 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/19 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Vascular disorders Hypertension	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/23 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	0.00% 0/22 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.	5.3% 1/19 • Number of events 1 • Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.