LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100; Vehicle
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of
      treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the
             trunk and/or limbs

          -  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)

          -  An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day
             0 (Visit 1)

          -  A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)

          -  A target lesion of a minimum of 5 cm at its longest axis and preferably not located on
             the extensor surface on an elbow or knee, scoring at least 1 for each of redness,
             thickness and scaliness, and at least 4 in total by the Investigator's Assessment of
             Severity of the Target Lesion

        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 randomisation:

               -  etanercept - within 4 weeks prior to randomisation

               -  adalimumab, infliximab - within 8 weeks prior to randomisation

               -  ustekinumab - within 16 weeks prior to randomisation

               -  other products - within 4 weeks/5 half-lives prior to randomisation (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 randomisation.

          -  Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug
             which has not yet been made available for clinical use following registration) within
             4 weeks/5 half-lives (whichever is longer) prior to randomisation.

          -  PUVA therapy within 4 weeks prior to randomisation.

          -  UVB therapy within 2 weeks prior to randomisation.

          -  Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within
             2 weeks prior to randomisation.

          -  Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D
             analogues or prescription shampoos within 2 weeks prior to randomisation.

          -  Planned initiation of, or changes to, concomitant medication that could affect
             psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors)
             during the trial.

          -  Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

          -  Previously randomised in this trial or any previously conducted trial of LEO 90100.