Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03594227 | ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis | PHASE2 | COMPLETED | 87 | — | — | Jun 11, 2018 | Jun 18, 2019 | Sep 16, 2020 | 25 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 400mg BID (Low dose) | ACTIVE_COMPARATOR | ATI-501 low dose - oral administration |
| 600mg BID (Mid dose) | ACTIVE_COMPARATOR | ATI-501 mid dose - oral administration |
| 800mg BID (High dose) | ACTIVE_COMPARATOR | ATI-501 high dose - oral administration |
| Placebo | PLACEBO_COMPARATOR | Placebo - oral administration |
| Name | Type | Description |
|---|---|---|
| ATI-501 400mg BID (Low dose) | DRUG | ATI-501 400mg BID oral low dose for oral administration |
| ATI-501 600mg BID (Mid dose) | DRUG | ATI-501 600mg BID oral mid dose for oral administration |
| ATI-501 800mg BID (High dose) | DRUG | ATI-501 800mg BID high dose for oral administration |
| Placebo | DRUG | Placebo - oral administration |
Inclusion Criteria: Subjects must meet the following criteria to be eligible for participation in the study: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF). 2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent. 3. Have a clinical diag...
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