Psoriasis Clinical Trial

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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
Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial

For subjects participating in HPA-axis testing, furthermore:

Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

722

Study ID:

NCT02899962

Recruitment Status:

Completed

Sponsor:

LEO Pharma

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There are 58 Locations for this study

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Center for Dermatology Clinical Research
Fremont California, 94538, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Colorado Medical Research Center
Denver Colorado, 80210, United States
International Dermatology Research
Miami Florida, 33144, United States
Arlington Dermatology
Arlington Heights Illinois, 60005, United States
Derm Research
Louisville Kentucky, 40217, United States
DermAssociates
Rockville Maryland, 20850, United States
Clarkston Skin Research
Clarkston Michigan, 48346, United States
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Beyer Research
Kalamazoo Michigan, 49009, United States
Psoriasis Treatment Center of Central NJ
East Windsor New Jersey, 08520, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Sadick Research Group
New York New York, 10075, United States
Skin Search of Rochester
Rochester New York, 14623, United States
UPMC Department of Dermatology
Pittsburgh Pennsylvania, 15213, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville Tennessee, 37072, United States
The Skin Wellness Center
Knoxville Tennessee, 37922, United States
Tennessee Clinical Research Center
Nashville Tennessee, 37215, United States
Clinical Trials of Texas
San Antonio Texas, 78229, United States
Center for Clinical Studies
Webster Texas, 77598, United States
Premier Clinical Research
Spokane Washington, 99202, United States
Dr. Chih-ho Hong Medical
Surrey British Columbia, V3R 6, Canada
Pacific Dermaesthetics
Vancouver British Columbia, V6E 4, Canada
Wiseman Dermatology Research
Winnipeg Manitoba, R3M 3, Canada
Maritime Medical Research Centre
Bathurst New Brunswick, E2A 4, Canada
Brunwick Dermatology Center
Fredericton New Brunswick, E3B 1, Canada
CCA Medical Research
Ajax Ontario, L1S 7, Canada
Dermatrials Research Incorporated
Hamilton Ontario, L8N 1, Canada
The Guenther Dermatology Research Centre
London Ontario, N6A 3, Canada
Lynderm Research
Markham Ontario, L3P 1, Canada
SKiN Center for Dermatology
Peterborough Ontario, K9J 5, Canada
K. Papp Clinical Research
Waterloo Ontario, N2J 1, Canada
Clinique du Dre Isabelle Delorme Inc
Quebec City Quebec, J2B 5, Canada
C.H.U. de Saint-Etienne Service de Dermatologie
Saint Etienne Saint-Etienne, 42055, France
CHRU de Brest - Hôpital Morvan
Brest , 29609, France
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
Nice , 06202, France
CHU de Rennes - Hôpital Pontchaillou
Rennes , 35033, France
Centre Hospitalier de Valence
Valence , 26000, France
Klinik und Poliklinik für Dermatologie
Dresden , 01307, Germany
Universitätsklinikum Erlangen
Erlangen , 91054, Germany
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
Essen , 54122, Germany
SRH Wald-Klinikum Gera
Gera , 07548, Germany
SCIderm GmbH
Hamburg , 20354, Germany
UKSH - Campus Lübeck
Lubeck , 23538, Germany
Michael Sebastian
Mahlow , 15831, Germany
LMU Poliklinik Derma & Allergo
Munchen , 80337, Germany
Gemein. Weber & Crainic
Schweinfurt , 97421, Germany
Małopolskie Centrum Kliniczne
Kraków , 31-12, Poland
NZOZ Med-laser
Lublin , 20-07, Poland
Solumed
Poznań , 60-42, Poland
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
Rzeszów , 35-03, Poland
Wansford and Kings Cliffe Prac
Wansford Cambridgeshire, PE8 6, United Kingdom
Ashgate Medical Practice
Chesterfield Derbyshire, S40 4, United Kingdom
Burbage Surgery
Burbage Leicstershire, LE10 , United Kingdom
Albany House Medical Centre
Wellingborough Northamptonshire, NN8 4, United Kingdom
Sherbourne Medical Centre
Leamington Spa Warwickshire, CV32 , United Kingdom
Chapel Allerton Hospital
Leeds West Yorkshire, LS7 4, United Kingdom
Dermatopharmacology Department
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

722

Study ID:

NCT02899962

Recruitment Status:

Completed

Sponsor:


LEO Pharma

How clear is this clinincal trial information?

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