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Also known as ATI-50002 topical solution
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 topical small molecule developed by Aclaris Therapeutics, Inc. (ticker ACRS) for dermatologic conditions. It is formulated as a topical solution and has been studied in alopecia areata, alopecia universalis, androgenetic alopecia, and vitiligo. It is not approved and remains in clinical development.
ATI-50002 targets JAK, a protein class of kinases involved in inflammatory signaling. By acting on JAK, the topical solution is designed to interfere with immune pathways relevant to hair loss and pigment disorders. Aclaris Therapeutics developed it as a small molecule applied directly to affected skin areas.
ATI-50002 is developed by Aclaris Therapeutics, Inc., which trades under the ticker ACRS. The company is the sponsor of the clinical studies evaluating the topical solution in dermatologic indications including alopecia areata, androgenetic alopecia, and vitiligo.
ATI-50002 is in Phase 2 development. Its Phase 2 trials in alopecia areata, alopecia universalis, alopecia totalis, androgenetic alopecia, and vitiligo have been completed. The drug is investigational and has not been approved by the FDA for any indication.
Completed Phase 2 trials of ATI-50002 include NCT03551821 in eyebrow loss due to alopecia areata, NCT03495817 in androgenetic alopecia, NCT03468855 in vitiligo, and NCT03315689 in alopecia universalis and alopecia totalis. All were conducted in the United States in adults aged 18 years and older.
Yes, ATI-50002 topical solution is the same asset as ATI-50002. The full name reflects its formulation, a solution applied to the skin, which is how it was administered in the Phase 2 studies across alopecia areata, androgenetic alopecia, and vitiligo.