Tepilamide Fumarate (PPC-06) Extended Release Tablets in Patients with Moderate-to-Severe Plaque Psoriasis: Safety and Efficacy Results from the Randomized, Double-blind, Placebo-controlled AFFIRM Study.

ABSTRACT:

Objective

Safe, effective, long-term oral therapies are needed for plaque psoriasis. This study aimed to assess the safety and effectiveness of tepilamide fumarate (a fumaric acid ester) extended-release tablets.

Methods

This Phase IIb, randomized, double-blind, placebo-controlled, 24-week, multicenter study treated adults with moderate-to-severe plaque psoriasis with tepilamide fumarate 400 mg once (QD) or twice daily (BID), 600 mg BID, or placebo. Coprimary endpoints were the proportion of patients achieving ≥75% reduction in the Psoriasis Area and Severity Index (PASI-75) and Investigator's Global Assessment (IGA) of clear or almost clear (≥2 points' reduction).

Results

A total of 426 patients were randomized (mean age 49.6 [±13.0] years). There was a ≥75% PASI red

SUBMITTER: Mrowietz U 

PROVIDER: S-EPMC8903235 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature