LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100 aerosol foam
* Drug: LEO 90100 aerosol foam vehicle


Participation Criteria
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Eligibility Criteria
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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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEO 90100 aerosol foam<br>Topical application twice weekly for 52 weeks | Drug: LEO 90100 aerosol foam<br>* LEO 90100 aerosol foam twice weekly<br>|
| Placebo Comparator: LEO 90100 aerosol foam vehicle<br>Topical application twice weekly for 52 weeks | Drug: LEO 90100 aerosol foam vehicle<br>* LEO 90100 aerosol foam vehicle twice weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Relapse | Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4 | From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Days in Remission During the Maintenance Phase | Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4 | From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal) | 
| Number of Relapses During the Maintenance Phase | Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product | From Randomisation (Week 4) until End of Treatment (Week 56) |