LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

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 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