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

NCT05249972 | Unknown Phase 3

• 1 other identifier: CRSC20008
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage change in Psoriasis Area and Severity Index (PASI) score

  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

  From baseline/randomization to Week 4 (Day 29±4)

Secondary Outcomes (4)

• 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

• Change in Scalp Physician's global assessment (ScPGA)

  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

Study Arms (3)

AKP02

EXPERIMENTAL

cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)

Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo

Enstilar

ACTIVE COMPARATOR

cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)

Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo

Placebo

PLACEBO COMPARATOR

cutaneous spray

Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo

Interventions

AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) DRUG

Topical cutaneous spray

AKP02; Enstilar; Placebo

Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) DRUG

Topical foam

AKP02; Enstilar; Placebo

Placebo OTHER

Placebo cutaneous spray

AKP02; Enstilar; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of oral estrogen therapy, excluding oral contraceptive pills
• Females who are pregnant, nursing, or planning a pregnancy
• Females of childbearing potential who do not agree to utilize an adequate form of contraception.
• Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)

Sponsors & Collaborators

• Lipidor AB: lead

Study Sites (1)

Lotus Multispeciality Hospital

Ahmedabad, India

RECRUITING

MeSH Terms

Interventions

calcipotriene; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Maria Klockare, PhD

  Lipidor AB

  STUDY DIRECTOR

Central Study Contacts

Maria Klockare

CONTACT

+46706232505; maria.klockare@lipidor.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, assessor blind, parallel group, three arms, active and placebo controlled study

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 22, 2022
• Study Start: January 24, 2022
• Primary Completion: August 11, 2022
• Study Completion: August 18, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)