Apremilast Phase4 Study on Quality of life in psoriasis manifestations

• Research type

  Research Study

• Full title

  A phase 4, multi-center, randomized, double-blind, placebo-controlled study of the impact of apremilast (CC-10004) on quality of life, efficacy, and safety in subjects with manifestations of plaque psoriasis and impaired quality of life

• IRAS ID

  253233

• Contact name

  Andrew Pink

• Contact email

  Andrew.Pink@gstt.nhs.uk

• Sponsor organisation

  Celgene International II SARL

• Eudract number

  2018-002850-58

• Duration of Study in the UK

  2 years, 6 months, 2 days

• Research summary

  Summary o Research
  Not yet available
  Psoriasis is an autoimmune condition that causes red, flaky, crusty patches of skin covered in silver scales. These patches can be anywhere on the body; however, it is known that some specific locations (for example, the scalp) are more frequently affected.

  Summary of Results
  Not ey available

  Psoriasis treatment recommendations depend on the type and severity of psoriasis, as traditionally determined by the area of skin affected and by the impact of psoriasis on quality of life. In particular, it has been described that some specific manifestations of psoriasis may be associated with a poorer quality of life (for example, psoriasis in the scalp, in palm and soles, in the genitals, in the nails or in visible locations).

  Apremilast (the study medication), has been proved to decrease the inflammation which is involved in the development of psoriasis. Based on this clinical evidence, apremilast is approved in Europe for use in patients who have moderate to severe psoriasis that has not responded to or cannot take other systemic treatments. Systemic treatments are defined as oral or injected medications that work throughout the entire body.

  This study, sponsored by Celgene International II SARL, is a phase 4, multi-centre, randomised, double-blind, placebo-controlled study.

  Approximately 255 subjects from 6 countries in Western Europe will take part in this study. The study is designed as a 52-week study consisting of 9 visits, with a 4-week post-treatment observational follow-up. During the study visits, patients will undergo procedures, such as physical examinations, blood tests and questionnaires completion.

  The purpose of this study is to assess the impact of apremilast on quality of life in patients with specific manifestations of plaque psoriasis which are associated with a high impairment of quality of life (i.e. psoriasis in the scalp, in palm and soles, in the genitals, in the nails or in visible locations).

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  19/LO/0040

• Date of REC Opinion

  19 Feb 2019

• REC opinion

  Further Information Favourable Opinion