Psoriasis vulgaris MedDRA version: 19.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Enstilar(R)
Product Name: Enstilar / LEO 90100 aerosol foam
Product Code: LEO 90100
Pharmaceutical Form: Cutaneous foam
INN
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with a maximum of 100 g of trial medication per week - 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) - A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 (‘mild’) for each of redness, thickness and scaliness, and at least 4 in total by the Investigator’s Assessment of Severity of the Target Lesion/Location For subjects participating in HPA-axis testing furthermore: - An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least ‘moderate’ affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1 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 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 132
Exclusion criteria
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 Visit 1: • etanercept – within 4 weeks prior to Visit 1 • adalimumab, infliximab – within 8 weeks prior to Visit 1 • ustekinumab – within 16 weeks prior to Visit 1 • secukinumab – within 12 weeks prior to Visit 1 • other products – within 4 weeks/5 half-lives prior to Visit 1 (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 Visit 1) - Systemic treatment with apremilast within 4 weeks prior to Visit 1 - Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1 - Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1 - Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial For subjects participating in HPA-axis testing furthermore: - Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of a twice weekly maintenance regimen with LEO 90100 compared to vehicle in the prevention of relapse in subjects with psoriasis vulgaris.; Secondary Objective: • To evaluate the long-term efficacy of LEO 90100 (up to 52 weeks) twice weekly maintenance regimen compared to vehicle in subjects with psoriasis • To evaluate the long-term safety of LEO 90100 (up to 52 weeks) in subjects with psoriasis vulgaris ;Primary end point(s): • Time to first relapse (at least ‘mild’according to the PGA);Timepoint(s) of evaluation of this end point: From Visit 2 (Randomisation) until Visit 15 (End of Treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of days in remission (‘clear’/‘almost clear’ according to the PGA) during the maintenance phase • Number of relapses during the maintenance phase ; Timepoint(s) of evaluation of this end point: - From Visit 2 (Randomisation) until Visit 15 (End of Treatment) - From Visit 2 (Randomisation) until Visit 15 (End of Treatment) | — |
Countries
Canada, France, Poland, United States
Contacts
Public ContactBente Tholstrup
LEO Pharma A/S
Outcome results
None listed