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Completed

NCT Number: NCT02888236

LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

A study of LEO 32731 in the treatment of psoriasis vulgaris

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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Universitätsmedizin Berlin, Dept. of Dermatology

Berlin, 10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 32731

Drug

LEO 32731 Placebo

Drug

Primary outcomes

  1. Psoriasis Area and Severity Index (PASI) at week 16

    Time frame: Week 16

Secondary outcomes

  1. 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

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

    Time frame: Week 16

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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