Psoriasis Vulgaris
Conditions
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.
Interventions
DRUGLEO 90100
DRUGVehicle
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
United States
Participant flow
Recruitment details
First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LEO 90100 LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) | 323 |
| Vehicle Aerosol foam vehicle | 103 |
| Total | 426 |
Baseline characteristics
| Characteristic | LEO 90100 | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 13.9 | 46.0 years STANDARD_DEVIATION 13.2 | 50.0 years STANDARD_DEVIATION 13.9 |
| Sex: Female, Male Female | 119 Participants | 54 Participants | 173 Participants |
| Sex: Female, Male Male | 204 Participants | 49 Participants | 253 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 323 | 15 / 103 |
| serious Total, serious adverse events | 2 / 323 | 0 / 103 |
Outcome results
Primary
Treatment Success According to IGA
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
Population: All randomised subjects were included in the full analysis set and analysed for efficacy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 90100 | Treatment Success According to IGA | 53.3 percentage of subjects |
| Vehicle | Treatment Success According to IGA | 4.8 percentage of subjects |
Comparison: Multiple imputations were used to handle missing data.p-value: <0.00195% CI: [9.72, 94.3]Mantel Haenszel
Secondary
m-PASI at Week 1
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
Population: All randomised subjects were included in the full analysis set and analysed for efficacy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LEO 90100 | m-PASI at Week 1 | 4.66 Scores on a scale |
| Vehicle | m-PASI at Week 1 | 5.93 Scores on a scale |
Comparison: 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.p-value: <0.00195% CI: [-1.76, -0.78]ANOVA
Secondary
m-PASI at Week 4
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
Population: All randomised subjects were included in the full analysis set and analysed for efficacy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LEO 90100 | m-PASI at Week 4 | 2.04 Scores on a scale |
| Vehicle | m-PASI at Week 4 | 5.33 Scores on a scale |
Comparison: 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.p-value: <0.00195% CI: [-3.9, -2.67]ANOVA