US-based biopharmaceutical firm XenoPort has started a Phase II clinical trial of its proprietary investigational next-generation fumaric acid product candidate ‘ XP23829’ for treatment of patients with psoriasis.
The multi-centre, randomised, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of XP23829 as a potential treatment of patients with moderate-to-severe chronic plaque-type psoriasis.
XenoPort chief medical officer Richard Kim said: "From this Phase II trial, we hope to further our understanding of the efficacy, safety and tolerability of XP23829."
In addition, the trial is designed to generate information on the effect of dose and treatment duration on potential reduction in psoriatic lesions and modulation of sub-populations of blood immune cells.
Based on enrolment rates of psoriasis studies carried out in the US, XenoPort expects top-line results of the trial in the third quarter of 2015.
Approximately 200 subjects are expected to be enrolled in the trial, which will include a screening and washout phase of up to four weeks, a 12-week treatment phase and a four-week post-treatment phase.
In the trial, eligible patients will be randomised to placebo or one of three treatment arms of XP23829: 400mg or 800mg once-daily or 400mg twice-daily.
The trial’s primary endpoint will examine the percent change in Psoriasis Area and Severity Index (PASI) score from baseline at the end of week 12, while the secondary endpoints will include the proportion of subjects who achieve a reduction of 75% or greater from baseline in PASI (PASI-75) score and subjects who achieve a Static Physicians Global Assessment (sPGA) score of ‘clear’ or ‘almost clear’.
Image: A person’s arm covered with plaque psoriasis. Photo: courtesy of Methoxyroxy.