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.
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.
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
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There are 58 Locations for this study
Fremont California, 94538, United States
Santa Monica California, 90404, United States
Denver Colorado, 80210, United States
Miami Florida, 33144, United States
Arlington Heights Illinois, 60005, United States
Louisville Kentucky, 40217, United States
Rockville Maryland, 20850, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Kalamazoo Michigan, 49009, United States
East Windsor New Jersey, 08520, United States
New York New York, 10029, United States
New York New York, 10075, United States
Rochester New York, 14623, United States
Pittsburgh Pennsylvania, 15213, United States
Goodlettsville Tennessee, 37072, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37215, United States
San Antonio Texas, 78229, United States
Webster Texas, 77598, United States
Spokane Washington, 99202, United States
Surrey British Columbia, V3R 6, Canada
Vancouver British Columbia, V6E 4, Canada
Winnipeg Manitoba, R3M 3, Canada
Bathurst New Brunswick, E2A 4, Canada
Fredericton New Brunswick, E3B 1, Canada
Ajax Ontario, L1S 7, Canada
Hamilton Ontario, L8N 1, Canada
London Ontario, N6A 3, Canada
Markham Ontario, L3P 1, Canada
Peterborough Ontario, K9J 5, Canada
Waterloo Ontario, N2J 1, Canada
Quebec City Quebec, J2B 5, Canada
Saint Etienne Saint-Etienne, 42055, France
Brest , 29609, France
Nice , 06202, France
Rennes , 35033, France
Valence , 26000, France
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 54122, Germany
Gera , 07548, Germany
Hamburg , 20354, Germany
Lubeck , 23538, Germany
Mahlow , 15831, Germany
Munchen , 80337, Germany
Schweinfurt , 97421, Germany
Kraków , 31-12, Poland
Lublin , 20-07, Poland
Poznań , 60-42, Poland
Rzeszów , 35-03, Poland
Wansford Cambridgeshire, PE8 6, United Kingdom
Chesterfield Derbyshire, S40 4, United Kingdom
Burbage Leicstershire, LE10 , United Kingdom
Wellingborough Northamptonshire, NN8 4, United Kingdom
Leamington Spa Warwickshire, CV32 , United Kingdom
Leeds West Yorkshire, LS7 4, United Kingdom
Salford , M6 8H, United Kingdom
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