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.
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Mild to Moderate Psoriasis
- Sponsor
- Lipidor AB
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- Percentage change in Psoriasis Area and Severity Index (PASI) score
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or non-pregnant female subjects aged \>18 years having either Fitzpatrick skin type I-III or IV-VI at the time of screening.
- •A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of body surface area (BSA) and PASI ≤10., that does not include the face, axilla and groin areas.
- •Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade 2 - 3).
- •A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site. The most severe lesion at Baseline should be identified as the target lesion.
- •Subjects must be willing to provide written informed consent.
- •Subjects must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
- •Subject must be in general good health as judged by the Investigator, based on medical history and physical examination.
Exclusion Criteria
- •Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
- •Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- •Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
- •Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
- •Subject with history of psoriasis unresponsive to topical treatments.
- •Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
- •Subjects with the diagnosis pustulosis palmo-plantaris
- •Subject in need of systemic treatment
- •Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy.
Arms & Interventions
AKP02
cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
Intervention: Placebo
AKP02
cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
Intervention: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
AKP02
cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
Intervention: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Enstilar
cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Intervention: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
Enstilar
cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Intervention: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Enstilar
cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Intervention: Placebo
Placebo
cutaneous spray
Intervention: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)
Placebo
cutaneous spray
Intervention: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
Placebo
cutaneous spray
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage change in Psoriasis Area and Severity Index (PASI) score
Time Frame: From baseline/randomization to Week 4 (Day 29±4)
Percentage change in Psoriasis Area and Severity Index (PASI) score from baseline/randomization to the end of treatment between test product (AKP02 cutaneous spray) and comparator product (Enstilar cutaneous foam). High score is worse
Secondary Outcomes
- Percentage change in Psoriasis Scalp Severity Index (PSSI) scores(From date of randomization until Week 4 (Day 29±4) post-randomization)
- Change in Physician's global assessment (PGA)(From date of randomization until Week 4 (Day 29±4) post-randomization)
- Frequency of adverse events and serious adverse events(From date of randomization until end of study)
- Change in Scalp Physician's global assessment (ScPGA)(From date of randomization until Week 4 (Day 29±4) post-randomization)