A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis

Summary

The study objectives are the following: 1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of moderate-to-severe chronic plaque-type psoriasis. 2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis. 3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.

Timeline

Start

2014-06

Primary completion

2015-05

Completion

2015-08

Outcome

Met primary endpoint

registry analysis (superiority test); XP23829 800 mg QD (Once Daily) vs Placebo; p = 0.001; Mixed Models Analysis NCT02173301 ↗

registry analysis (superiority test); XP23829 400 mg BID (Twice Daily) vs Placebo; p <0.001; Mixed Models Analysis NCT02173301 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tepilamide Fumarate	Small molecule	400 mg	—
Subject	Tepilamide Fumarate	Small molecule	800 mg	—

Indications