leo 90100 twice weekly maintenance regimen for psoriasis vulgaris

Conditions: 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.

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