LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.

Official Title
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A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris.

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100
* Drug: Betamethasone plus calcipotriol
* Drug: Ointment vehicle
* Drug: LEO 90100 vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent obtained prior to any trial related activities (including washout period). Age 18 years or above Either sex Any race or ethnicity All skin types Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1). Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). Able to communicate with the investigator and understand and comply with the requirements of the study. 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, alefacept, infliximab - within 8 weeks prior to randomisation ustekinumab - within 16 weeks prior to randomisation other products - 4 weeks/5 half-lives (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. Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study. Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris. Known or suspected disorders of calcium metabolism associated with hypercalcaemia. Known or suspected severe renal insufficiency or severe hepatic disorders. Known or suspected hypersensitivity to component(s) of the investigational products. Current participation in any other interventional clinical study. Previously randomised in this study. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: LEO 90100 vehicle<br>Aerosol foam with no active ingredient | Drug: LEO 90100 vehicle<br> <br> |
| Active Comparator: Betamethasone plus calcipotriol<br>Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment | Drug: Betamethasone plus calcipotriol<br> <br> |
| Experimental: LEO 90100<br>LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) | Drug: LEO 90100<br> <br> |
| Placebo Comparator: Ointment vehicle<br>Ointment with no active ingredients | Drug: Ointment vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. | Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. | 4 weeks |