LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01866163
• Collaborator: (none)
• Enrollment: 426
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 84.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: LEO 90100; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 426 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LEO 90100 LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Drug: LEO 90100
Placebo Comparator: Vehicle Aerosol foam vehicle	Drug: Vehicle

Outcome Measures

Primary Outcome Measures

1. Treatment Success According to IGA [4 weeks]

   Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe

Secondary Outcome Measures

1. m-PASI at Week 4 [4 weeks]

   The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).

2. m-PASI at Week 1 [1 week]

   The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Dermatology	Saint Louis	Missouri	United States	63117

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Craig Leonardi, Central Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01866163
• Other Study ID Numbers: LP0053-1001
• First Posted: May 31, 2013
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013
Pre-assignment Detail	Prior to randomisation, the subject entered a washout phase (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The wash-out/screening phase could last for up to 4 weeks, depending on which disallowed treatments the subject received.

Arm/Group Title	LEO 90100	Vehicle
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Aerosol foam vehicle
Period Title: Overall Study
STARTED	323	103
COMPLETED	313	99
NOT COMPLETED	10	4

Baseline Characteristics

Arm/Group Title	LEO 90100	Vehicle	Total
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Aerosol foam vehicle	Total of all reporting groups
Overall Participants	323	103	426
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.2 (13.9)	46.0 (13.2)	50.0 (13.9)
Sex: Female, Male (Count of Participants)
Female	119 36.8%	54 52.4%	173 40.6%
Male	204 63.2%	49 47.6%	253 59.4%

Outcome Measures

1. Primary Outcome

Title	Treatment Success According to IGA
Description	Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All randomised subjects were included in the full analysis set and analysed for efficacy.

Arm/Group Title	LEO 90100	Vehicle
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Aerosol foam vehicle
Measure Participants	323	103
Number [percentage of subjects]	53.3	4.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100, Vehicle
	Comments	Multiple imputations were used to handle missing data.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mantel Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	30.27
	Confidence Interval	(2-Sided) 95%; 9.72 to 94.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	m-PASI at Week 4
Description	The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All randomised subjects were included in the full analysis set and analysed for efficacy.

Arm/Group Title	LEO 90100	Vehicle
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Aerosol foam vehicle
Measure Participants	323	103
Mean (95% Confidence Interval) [Scores on a scale]	2.04	5.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100, Vehicle
	Comments	The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.28
	Confidence Interval	(2-Sided) 95%; -3.90 to -2.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	m-PASI at Week 1
Description	The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

All randomised subjects were included in the full analysis set and analysed for efficacy.

Arm/Group Title	LEO 90100	Vehicle
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Aerosol foam vehicle
Measure Participants	323	103
Mean (95% Confidence Interval) [Scores on a scale]	4.66	5.93

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100, Vehicle
	Comments	The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.27
	Confidence Interval	(2-Sided) 95%; -1.76 to -0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	LEO 90100		Vehicle
Arm/Group Description	LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)		Aerosol foam vehicle
All Cause Mortality
	LEO 90100		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LEO 90100		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/323 (0.6%)		0/103 (0%)
Psychiatric disorders
Substance induced psychotic disorder	1/323 (0.3%)	1	0/103 (0%)	0
Bipolar disorder	1/323 (0.3%)	1	0/103 (0%)	0
Other (Not Including Serious) Adverse Events
	LEO 90100		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/323 (5.6%)		15/103 (14.6%)
Gastrointestinal disorders
Diarrhoea	2/323 (0.6%)	2	1/103 (1%)	1
Nausea	2/323 (0.6%)	2	0/103 (0%)	0
General disorders
Application site pain	3/323 (0.9%)	4	2/103 (1.9%)	2
Application site dryness	0/323 (0%)	0	1/103 (1%)	1
Application site erosion	0/323 (0%)	0	1/103 (1%)	1
Application site erythema	0/323 (0%)	0	1/103 (1%)	1
Application site oedema	0/323 (0%)	0	1/103 (1%)	1
Infections and infestations
Nasopharyngitis	6/323 (1.9%)	6	0/103 (0%)	0
Eye infection	0/323 (0%)	0	1/103 (1%)	1
Gastroenteritis viral	0/323 (0%)	0	1/103 (1%)	1
Streptococcal infection	0/323 (0%)	0	1/103 (1%)	1
Injury, poisoning and procedural complications
Ligament sprain	0/323 (0%)	0	1/103 (1%)	1
Sunburn	0/323 (0%)	0	1/103 (1%)	1
Investigations
Blood pressure increased	3/323 (0.9%)	4	0/103 (0%)	0
Musculoskeletal and connective tissue disorders
Flank pain	2/323 (0.6%)	2	0/103 (0%)	0
Pain in extremity	0/323 (0%)	0	1/103 (1%)	1
Nervous system disorders
Dizziness	0/323 (0%)	0	1/103 (1%)	1
Skin and subcutaneous tissue disorders
Angioedema	0/323 (0%)	0	1/103 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.