LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

INCLUSION CRITERIA:

• A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunkand/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 andskin 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 thebody (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 theInvestigator'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 atleast 'moderate' affecting between 10 and 30% of the body surface area (BSA) excludingpsoriatic lesions of genitals and skin folds at Visit 1.

EXCLUSION CRITERIA:

• Systemic treatment with biological therapies, whether marketed or not, with a possibleeffect 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 islonger)

• Systemic treatment with all other therapies with a possible effect on psoriasisvulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and otherimmunosuppressants) 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 beprohibited 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 othermedication known to affect cortisol levels or HPA axis integrity within 4 weeks priorto baseline