Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.

Official Title
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Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (all subjects) Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA. Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area. A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA. PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1. PGA score of at least mild on scalp at SV1, SV2 and V1. A serum albumin-corrected calcium below the upper reference limit at SV2. Inclusion Criteria (for subjects performing HPA axis assessment) Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA. Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area. PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1. PGA score of at least moderate on scalp at SV1, SV2 and V1. Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge). Exclusion Criteria (all subjects): A history of hypersensitivity to any component of LEO 90100. Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial: etanercept - within 4 weeks prior to V1 adalimumab, infliximab - within 2 months prior to V1 ustekinumab - within 4 months prior to V1 experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1 Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial. PUVA therapy within 4 weeks prior to V1. UVB therapy within 2 weeks prior to V1 or during the trial. Exclusion Criteria (for subjects performing HPA axis assessment): A history of serious allergy, allergic asthma or serious allergic skin rash. Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide) Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial. Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 90100<br> | Drug: LEO 90100<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events (AEs) | Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From Week -1 to Week 8 | 
| Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. | 30 minutes after ACTH-challenge at Week 4 | 
| Change in Albumin-corrected Serum Calcium From Baseline to Week 4 | Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From baseline to Week 4 | 
| Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 | Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From baseline to Week 4 | 
| Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 | Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing. | From baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. | 30 and 60 minutes after ACTH-challenge at Week 4 | 
| Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 | Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing. | From baseline to Week 4 | 
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Week 4 | 
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Week 4 | 
| Percentage Change in PASI From Baseline to Week 4 | Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease. | From baseline to Week 4 | 
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Week 4 | 
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Week 4 | 
| Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 | Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome. | From baseline to Week 4 |