This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US). Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms: 1. PPC-06 400 mg once daily (QD) 2. PPC-06 400 mg BID 3. PPC-06 600 mg BID 4. Placebo BID The maximum study duration for each subject will be approximately 29 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
426
Tepilamide Fumarate 400 mg tablet once per day
Tepilamide Fumarate tablets 400 mg twice per day
Tepilamide Fumarate tablets 600 mg twice per day
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24
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.
Time frame: End of Week 24
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1
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.
Time frame: End of Week 24
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white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Site 144
Glendale, Arizona, United States
Site 167
Phoenix, Arizona, United States
Site 158
Phoenix, Arizona, United States
Site 170
Tempe, Arizona, United States
Site 157
Bryant, Arkansas, United States
Site 125
Rogers, Arkansas, United States
Site 133
Fountain Valley, California, United States
Site 107
Fremont, California, United States
Site 121
Fresno, California, United States
Site 153
Fullerton, California, United States
...and 64 more locations