Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
122-0551 Foam · 1 trial · 1 indication
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| Active Arm | EXPERIMENTAL | 122-0551 Foam, topically applied twice daily for two weeks |
| Vehicle Arm | PLACEBO_COMPARATOR | Vehicle Foam, topically applied twice daily for two weeks |
| Name | Type | Description |
|---|---|---|
| 122-0551 Foam | DRUG | 122-0551 Foam applied twice daily to treat psoriasis |
| Vehicle Foam | DRUG | Vehicle Foam applied twice daily to treat psoriasis |
Inclusion Criteria: * Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area. * Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start. * If subject is a woman of childbea...
122-0551 Foam is an investigational small molecule being developed for the treatment of plaque psoriasis. It is a topical foam formulation designed for application to the skin. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
122-0551 Foam is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for plaque psoriasis.
122-0551 Foam is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its effects in patients with plaque psoriasis.
122-0551 Foam has one completed Phase 3 clinical trial, identified as NCT02367911. This study, titled "A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis," enrolled 144 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No alternative names for 122-0551 Foam have been reported. It is identified solely by this name in clinical trial records. The drug is being studied specifically for plaque psoriasis and is not known to be marketed under any other brand name.