Psoriasis vulgaris MedDRA version: 18.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or above 2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2 to 30% of the Body Surface Area (BSA) 3. Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs 4. m-PASI score of at least 2 on the trunk and limbs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 2. 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) 3. 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) 4. Subjects who have received treatment with any non-marketed 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. 5. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation 6. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation 7. Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation 8. Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation 9. Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris;Secondary Objective: To compare the safety and efficacy of treatment with LEO 90100 to that of calcipotriol BDP gel for up to 12 weeks in subjects with psoriasis vulgaris;Primary end point(s): 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 PGA at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel;Timepoint(s) of evaluation of this end point: 4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PASI 75 at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel - Time to ‘treatment success’ according to PGA - Change in itch as assessed by the Visual Analogue Scale (VAS) from baseline (Day 0) to Week 4 for LEO 90100 and to Week 8 for calcipotriol BDP at Week 8;Timepoint(s) of evaluation of this end point: 4 and 8 weeks | — |
Countries
France, United States
Contacts
Public ContactKathrine Drud-Olsson
LEO Pharma A/S
Outcome results
None listed