LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 32731 Placebo; Drug: LEO 32731

Study type: Interventional

Funder types: Industry

Identifiers

NCT02888236

LP0058-1072

Details and patient eligibility

About

A study of LEO 32731 in the treatment of psoriasis vulgaris

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

LEO 32731 tablet

Experimental group

Description:

LEO 32731 30 mg two times daily for 16 weeks

Treatment:

Drug: LEO 32731

LEO 32731 Placebo tablet

Placebo Comparator group

Description:

LEO 32731 placebo two times daily for 16 weeks

Treatment:

Drug: LEO 32731 Placebo