Psoriasis Vulgaris
Conditions
Keywords
Psoriasis
Brief summary
A study of LEO 32731 in the treatment of psoriasis vulgaris
Detailed description
This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris
Interventions
DRUGLEO 32731
DRUGLEO 32731 Placebo
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Aged between 18 years and 65. * Males or females of non-childbearing potential. * Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis * Have moderate to severe psoriasis vulgaris * Candidates of systemic anti-psoriatic treatment and/or phototherapy
Exclusion criteria
* Subjects with therapy resistant psoriasis * Previously exposed to apremilast * Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris * Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index (PASI) at week 16 | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16 | Week 16 |
| Itch evaluated by itch Numerical Rating Scale (NRS) at week 16 | Week 16 |
Countries
Germany
Outcome results
None listed