A Phase III Study in Subjects With Mild to Moderate Psoriasis. — AKVANO-AKP02  

Mild to Moderate Psoriasis Clinical Trial

Official title: A Randomized Phase III, Three-parallel Arm, Assessor Blind, Multi-centre Study to Evaluate the Efficacy, Safety and Tolerability of AKP02 Cutaneous Spray Versus Enstilar Cutaneous Foam in Subjects With Mild to Moderate Psoriasis.

Status Recruiting

Clinical Trial Summary

A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in subjects with mild to moderate plaque psoriasis.

Clinical Trial Description

Eligible subjects (in total 294) will be randomized in a 3:3:1 fashion to receive AKP02 cutaneous spray, Enstilar cutaneous foam or the AKVANO vehicle spray, respectively. The randomization will be stratified by skin type (Fitzpatrick skin type I-III and Fitzpatrick skin type IV-VI). At least 25 % of the subjects randomized in the study should belong to Fitzpatrick skin type I-III and at least 25 % to Fitzpatrick skin type IV-VI. ;

Related Conditions & MeSH terms

• Mild to Moderate Psoriasis
• Psoriasis

• NCT number: NCT05249972
• Study type: Interventional
• Source: Lipidor AB
• Contact: Maria Klockare
• Phone: +46706232505
• Email: maria.klockare@lipidor.se
• Status: Recruiting
• Phase: Phase 3
• Start date: January 24, 2022
• Completion date: August 18, 2022