LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100 aerosol foam; LEO 90100 aerosol foam vehicle
Intervention description: LEO 90100 aerosol foam twice weekly; LEO 90100 aerosol foam vehicle twice weekly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 722.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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