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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris | Clinical Trials | Clareo Health

COMPLETEDPHASE3

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

NCT02899962•LEO Pharma

Summary

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris. A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Detailed Description

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle. If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with maximum of 100 g of trial medication per week
•Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)
•A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 ('mild') for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion/Location
•For subjects participating in hypothalamic-pituitary-adrenal (HPA)-axis testing, furthermore:
•An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least 'moderate' affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1.

Exclusion Criteria

•Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:
•* etanercept - within 4 weeks prior to Visit 1
•* adalimumab, infliximab - within 8 weeks prior to Visit 1
•* ustekinumab - within 16 weeks prior to Visit 1
•* secukinumab - within 12 weeks prior to Visit 1
•* other products - within 4 weeks/5 half-lives prior to Visit 1 (whichever is longer)
•Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to Visit 1
•Systemic treatment with apremilast within 4 weeks prior to Visit 1
•Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
•Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
+3 more criteria

Locations (58)

Center for Dermatology Clinical Research

Fremont, California, United States

Clinical Science Institute

Santa Monica, California, United States

Colorado Medical Research Center

Denver, Colorado, United States

International Dermatology Research

Miami, Florida, United States

Arlington Dermatology

Arlington Heights, Illinois, United States

Derm Research

Louisville, Kentucky, United States

DermAssociates

Rockville, Maryland, United States

Clarkston Skin Research

Clarkston, Michigan, United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Beyer Research

Kalamazoo, Michigan, United States

Key Dates

Start Date

February 15, 2017

Primary Completion Date

June 26, 2019

Completion Date

June 26, 2019

Last Updated

August 20, 2020

Enrollment

722

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

LEO 90100 aerosol foam

DRUG

LEO 90100 aerosol foam vehicle

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study