Psoriasis vulgaris MedDRA version: 20.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Enstilar®
Product Name: Enstilar / LEO 90100 aerosol foam
Product Code: LEO 90100
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: Calcipotriol
CAS Number: 147657-22-5
Other descri
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For an eligible subject, all inclusion criteria must be answered “yes”. 1. Signed and dated informed consent has been obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Age 18 years or above at screening 3. A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs at screening 4. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-15 % of the body surface area (BSA) at screening and enrolment (Day 1) 5. An Investigator's Global Assessment of disease severity (IGA) of at least ‘mild’ on trunk and limbs at screening and enrolment (Day 1) 6. A m-PASI score of at least 2 at screening and enrolment (Day 1) 7. A least one target lesion/target location of at least 3 cm at its longest axis located on the trunk or limbs (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 target lesion TSS 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: For an eligible subject, all exclusion criteria must be answered “no”. 1. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to screening: • etanercept – within 4 weeks prior to screening • adalimumab, infliximab – within 8 weeks prior to screening • ustekinumab – within 16 weeks prior to screening • secukinumab – within 12 weeks prior to screening • other products – within 4 weeks/5 half-lives prior to screening (whichever is longer) 2. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressant drugs) within 4 weeks prior to screening 3. Systemic treatment with apremilast within 4 weeks prior to screening 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 screening 5. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to screening 6. Ultraviolet B (UVB) therapy within 2 weeks prior to screening 7. Topical anti-psoriatic treatment on the trunk and/or limbs (except for emollients) within 2 weeks prior to screening 8. Topical treatment on the face, scalp and skin folds with corticosteroids (except for emollients, non-steroid medicated shampoos and low potency corticosteroids on sensitive areas), or vitamin D supplements > 400 IU/day within 2 weeks prior to Screening a. Stable dose of Vitamin D supplements = 400 IU/Day is permitted 9. 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 10. Pre-existing overt atrophy or telangiectasia in treatment areas 11. 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 12. Diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis at screening 13. Subjects with any of the following conditions present on the treatment area at screening: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, acne vulgaris, atrophic skin, atrophic striae, fragility of skin veins, ichthyosis, acne rosacea, rosacea, ulcers and wounds 14. Other skin disorders (e.g. seborrheic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis 15. Planned excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps etc.) of area(s) to be treated with trial medication during the trial 16. Known or suspected disorders of calcium metabolism associated with hypercalcemia 17. Known or suspected hypersensitivity to component(s) of medicinal products 18. Current participation in any other interventional clinical trial 19. Active substance abuse or a history of substance abuse within 6 months of screening 20. Language barrier, mental incapacity, unwillingness or inability to adequately understand or comply with trial procedures. (e.g. due to alcoholism, drug addiction or psychotic state). 21. Subjects who are institutionalized by court order or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To generate adherence and treatment data with LEO 90100 once daily using a tracker.;Secondary Objective: To evaluate efficacy of LEO 90100 once daily. To evaluate safety and tolerability of LEO 90100 once daily;Primary end point(s): Patient adherence based on tracker measurements;Timepoint(s) of evaluation of this end point: From baseline to day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to Day 29 in overall TSS score. Subjects achieving ‘treatment success’ (‘clear’ or ‘almost clear’ with at least a 2-grade improvement) according to the IGA at Day 29. Treatment emergent AEs (including AEs relating to local tolerability).;Timepoint(s) of evaluation of this end point: From baseline to day 29 | — |
Countries
Denmark
Contacts
Public ContactHanne Børgesen
LEO Pharma A/S
Outcome results
None listed