NCT05249972

A Phase III Study in Subjects With Mild to Moderate Psoriasis.

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Lipidor AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mild to Moderate Psoriasis

Interventions

Type	Name	Description
DRUG	AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)	Topical cutaneous spray
DRUG	Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)	Topical foam
OTHER	Placebo	Placebo cutaneous spray

Timeline

• Start date: 2022-01-24
• Primary completion: 2022-08-11
• Completion: 2022-08-18
• First posted: 2022-02-22
• Last updated: 2022-08-10

Locations

1 site across 1 country: India