Study of the Efficacy and Safety of Topical P-3073 in the Treatment of Mild to Moderate Psoriatic Fingernail/s

Nail Psoriasis Clinical Trial

Official title: A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis

Status Not yet recruiting

Clinical Trial Summary

The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.

Clinical Trial Description

This phase III study versus vehicle will be conducted to confirm the clinical efficacy and safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild-to-moderate plaque psoriasis.

To evaluate the safety and the efficacy of P-3073 nail solution in the treatment of nail psoriasis, a phase II study to compare P-3073 versus placebo and versus another active compound, P-3072 containing cyclosporine 5%, was performed.

The primary objective of the present phase III study will be the assess the efficacy of topical P-3073 in the treatment of mild to moderate psoriatic fingernail/s. The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI). The mild to moderate status will be defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline).

The secondary objectives will be:

• To assess if the topical treatment with P-3073 is able to improve the quality of life and discomfort in patients with psoriatic fingernail.

• To assess the safety and tolerability of topical P-3073 in the treatment of psoriatic fingernail.

The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening (NAPSI =1 or ≥2) according to a computer-generated randomization list.

The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.

The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily, preferably at bedtime, on clean and dry nail(s). ;

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

• NCT number: NCT03209388
• Study type: Interventional
• Source: Almirall, S.A.
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 24, 2017
• Completion date: October 28, 2018