LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888236
• Other study ID #: LP0058-1072
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2016
• Last updated: August 25, 2017
• Start date: September 2016
• Est. completion date: July 6, 2017

Study information

• Verified date: August 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study of LEO 32731 in the treatment of psoriasis vulgaris

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 6, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 32731

• LEO 32731 Placebo

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin, Dept. of Dermatology	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI) at week 16		Week 16
Secondary	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
Secondary	Itch evaluated by itch Numerical Rating Scale (NRS) at week 16		Week 16