LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:February 15, 2017
End Date:May 2019

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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.

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.

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 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
We found this trial at
22
sites
911 Park Avenue
New York, New York 10075
212-710-9855
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New York, NY
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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1100 West Central Road
Arlington Heights, Illinois 60005
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Arlington Heights, IL
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Clarkston, Michigan 48346
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Clarkston, MI
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Denver, Colorado 80210
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Denver, CO
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Detroit, MI
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East Windsor, New Jersey 08520
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East Windsor, NJ
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Fremont, California 94538
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Fremont, CA
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Goodlettsville, TN
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Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Knoxville, Tennessee 37922
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Knoxville, TN
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Louisville, Kentucky 40217
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Louisville, KY
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Miami, FL
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Nashville, Tennessee 37215
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Nashville, TN
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New York, New York 10029
Phone: 212-241-9728
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New York, NY
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Rochester, New York 14623
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Rochester, NY
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Rockville, Maryland 20850
Phone: 301-355-3183
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Rockville, MD
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Santa Monica, California 90404
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Santa Monica, CA
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Spokane, Washington 99204
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Spokane, WA
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Surrey, British Columbia
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Surrey,
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Webster, Texas 77598
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Webster, TX
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