Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PPC-06 · 1 trial · 1 indication
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1) Score Grade Definition 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.
| Arm | Type | Description |
|---|---|---|
| PPC-06 400 mg QD | EXPERIMENTAL | Tepilamide Fumarate 400 mg once per day |
| PPC-06 400 mg BID | EXPERIMENTAL | Tepilamide Fumarate 400 mg twice per day |
| PPC-06 600 mg BID | EXPERIMENTAL | Tepilamide Fumarate 600 mg twice per day |
| Placebo BID | PLACEBO_COMPARATOR | White placebo tablet to mimic Tepilamide Fumarate |
| Name | Type | Description |
|---|---|---|
| PPC-06 400 mg QD | DRUG | Tepilamide Fumarate 400 mg tablet once per day |
| PPC-06 400 mg BID | DRUG | Tepilamide Fumarate tablets 400 mg twice per day |
| PPC-06 600 mg | DRUG | Tepilamide Fumarate tablets 600 mg twice per day |
| Placebo | DRUG | white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets |
Inclusion Criteria: * Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent). * Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or s...
PPC-06 is an investigational small molecule being developed for the treatment of psoriasis. It is currently in Phase 2 clinical development and has completed a randomized, double-blind, placebo-controlled trial in the United States.
PPC-06 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY.
PPC-06 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed.
PPC-06 has one completed clinical trial, identified as NCT03421197, which assessed the efficacy and safety of PPC-06 (Tepilamide Fumarate) in 426 participants with psoriasis. The trial was randomized, double-blind, and placebo-controlled.
Yes, PPC-06 is also known as Tepilamide Fumarate. The clinical trial NCT03421197 refers to the drug as PPC-06 (Tepilamide Fumarate).