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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LEO 90100
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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:

    1. etanercept - within 4 weeks prior to V1
    2. adalimumab, infliximab - within 2 months prior to V1
    3. ustekinumab - within 4 months prior to V1
    4. 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.

Sites / Locations

  • Lucile Packard Children's Hospital at Stanford
  • Redwood Family Dermatology
  • Hamzavi Dermatology
  • Greenwich Village Dermatology
  • Skin Speciality Dermatology
  • Dermatology Treatment and Research Center PA
  • UMC St Radboud
  • MULTIKLINIKA SALUTE Sp zo.o.
  • Spitalul Clinic de Boli Infectioase si Tropicale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEO 90100

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 12, 2015
Last Updated
January 14, 2019
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02387853
Brief Title
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 90100
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LEO 90100
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events (AEs)
Description
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.
Time Frame
From Week -1 to Week 8
Title
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Description
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.
Time Frame
30 minutes after ACTH-challenge at Week 4
Title
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4
Title
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4
Title
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4
Secondary Outcome Measure Information:
Title
Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Description
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.
Time Frame
30 and 60 minutes after ACTH-challenge at Week 4
Title
Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4
Title
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
Description
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.
Time Frame
Week 4
Title
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
Description
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.
Time Frame
Week 4
Title
Percentage Change in PASI From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4
Title
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
Description
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.
Time Frame
Week 4
Title
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
Description
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.
Time Frame
Week 4
Title
Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
Description
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.
Time Frame
From baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Seyger, MD
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Redwood Family Dermatology
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403-2805
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059-3526
Country
United States
Facility Name
Greenwich Village Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Skin Speciality Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Dermatology Treatment and Research Center PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-5808
Country
United States
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
MULTIKLINIKA SALUTE Sp zo.o.
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Spitalul Clinic de Boli Infectioase si Tropicale
City
Bucharest
ZIP/Postal Code
030303
Country
Romania

12. IPD Sharing Statement

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

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