Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATI-50002 · 4 trials · 7 indications
Determination of the amount of hair in the affected area. Clinician's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No terminal hairs are visible in the affected area(s) 1. A little eyebrow hair: Occasional terminal hairs are visible in the affected area(s) 2. Some eyebrow hair: Numerous terminal hairs are visible in the affected area(s) 3. Most eyebrow hair: Mostly complete eyebrow regrowth with terminal hair in the affected area(s) 4. Full eyebrow hair: Complete eyebrow regrowth with terminal hair in the affected area(s)
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.
ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).
| Arm | Type | Description |
|---|---|---|
| ATI-50002 Topical Solution | EXPERIMENTAL | ATI-50002 Topical Solution |
| Vehicle | PLACEBO_COMPARATOR | Vehicle |
| Active | EXPERIMENTAL | ATI-50002 Topical Solution |
| Name | Type | Description |
|---|---|---|
| ATI-50002 | DRUG | Topical Solution |
| ATI-50002 topical solution | DRUG | Topical Solution administered twice daily |
| Vehicle | DRUG | Vehicle Topical Solution |
Inclusion Criteria: 1. Subject is at least 18 years of age. 2. Subject has, based on a subject history and clinical examination, a clinical diagnosis of AA, AU or AT with no eyebrow hair in the affected area(s) and no eyebrow regrowth over the previous 6 months. Affected area is defined as the area...
ATI-50002 is an investigational small molecule being developed for dermatology conditions including alopecia areata, vitiligo, androgenetic alopecia, and alopecia universalis. It is a topical solution studied in Phase 2 clinical trials. ATI-50002 is not approved by the FDA and remains in clinical development.
ATI-50002 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ACRS. The company has conducted Phase 2 clinical trials of ATI-50002 for hair loss and skin pigmentation disorders.
ATI-50002 is in Phase 2 clinical development. Multiple Phase 2 trials have been completed, including studies in alopecia universalis, vitiligo, androgenetic alopecia, and eyebrow loss due to alopecia areata. The drug is investigational and has not received FDA approval.
ATI-50002 has completed Phase 2 trials including NCT03315689 in alopecia universalis and totalis, NCT03468855 in vitiligo, NCT03495817 in androgenetic alopecia, and NCT03551821 in eyebrow loss due to alopecia areata. All trials were conducted in the United States.
ATI-50002 is a distinct investigational topical small molecule developed by Aclaris Therapeutics. It has been studied specifically for alopecia areata, alopecia universalis, androgenetic alopecia, and vitiligo. No alternative names for ATI-50002 have been reported.