Psoriasis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 24-Week Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) Extended Release Tablets in Subjects With Moderate-to-Severe Plaque Psoriasis (AFFIRM)
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. ;
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