LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
- Registration Number
- NCT02888236
- Lead Sponsor
- LEO Pharma
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LEO 32731 tablet LEO 32731 LEO 32731 30 mg two times daily for 16 weeks LEO 32731 Placebo tablet LEO 32731 Placebo LEO 32731 placebo two times daily for 16 weeks
- Primary Outcome Measures
Name Time Method Psoriasis Area and Severity Index (PASI) at week 16 Week 16
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Charité Universitätsmedizin Berlin, Dept. of Dermatology
🇩🇪Berlin, Germany