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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

EUCTR2015‐005279‐25‐DE.

Methods Randomised, placebo‐controlled, parallel‐group, double‐blind
Date of study: September 2016 (starting date)
Location: Germany
Participants Total sample size: 36
Inclusion criteria
  • Signed and dated informed consent

  • Aged between 18 years and 65

  • Men or women 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
  • Patients 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

Interventions Intervention 1: LEO 32731 30 mg twice a day for 16 weeks
Intervention 2: placebo
Outcomes Primary outcome
  • Psoriasis Area and Severity Index (PASI) at week 16


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

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

Notes Study completion date on ClinicalTrials.gov July 2017
NCT02888236