LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

LEO Pharma36 enrolled

Overview

A study of LEO 32731 in the treatment of psoriasis vulgaris

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

LEO 32731DRUG

LEO 32731 PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité Universitätsmedizin Berlin, Dept. of Dermatology

Berlin, Germany

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index (PASI) at week 16

Time frame: Week 16

Secondary Outcomes

Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16

Time frame: Week 16

Itch evaluated by itch Numerical Rating Scale (NRS) at week 16

Time frame: Week 16

Data from ClinicalTrials.gov

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