Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A-101 40 · 1 trial · 1 indication
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
| Arm | Type | Description |
|---|---|---|
| A-101 Solution 40 | EXPERIMENTAL | A-101 Solution 40% administered once per week |
| A-101 Solution 45 | EXPERIMENTAL | A-101 Solution 45% administered once per week |
| Vehicle Solution | PLACEBO_COMPARATOR | Vehicle Solution administered once per week |
| Name | Type | Description |
|---|---|---|
| A-101 Solution 40 | DRUG | - |
| A-101 Solution 45 | DRUG | - |
| Vehicle Solution | DRUG | - |
Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject has a clinical diagnosis of common warts 3. Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities: * Have a longest axis that is 3mm to 10mm * Have a thickness ≤3mm * Be a discrete lesion ...
A-101 40 is an investigational small molecule topical solution being developed for dermatological conditions, specifically common warts and dermatosis papulosa nigra (DPN). It is not FDA approved and remains in clinical development.
A-101 40 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACRS.
A-101 40 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for common warts and one for dermatosis papulosa nigra, but the drug remains investigational and is not yet approved.
A-101 40 has completed two Phase 2 trials: NCT02669862 in common warts with 98 participants, and NCT03224598 in dermatosis papulosa nigra with 39 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.
A-101 40 is a small molecule topical solution. Its specific molecular target has not been disclosed in the available clinical trial information.