A 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

  • STATUS
    Not Recruiting
  • End date
    Nov 5, 2021
  • participants needed
    255
  • sponsor
    Amgen
Updated on 26 January 2021
cervical cap
cyclosporine
methotrexate
hormonal contraception
systemic therapy
option 2
cc-10004
puva
psoralen
apremilast
plaque psoriasis
acitretin
scalp psoriasis
nail psoriasis
palmoplantar psoriasis

Summary

This is a Phase 4, multi-center, randomized, placebo-controlled, double-blind study of the impact of apremilast on quality of life, efficacy, and safety in subjects with manifestations of plaque psoriasis and impaired quality of life.

Approximately 255 subjects will be randomized 2 (apremilast):1 (placebo) in approximately 6 to 10 countries in Western Europe. Subjects will be block-randomized equally to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). If subjects present with multiple manifestations, they will be allocated to the manifestation which is most severe, as determined by the subject.

However, all manifestations will be assessed for efficacy at each study visit.

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders
Treatment Placebo, Apremilast (CC-10004)
Clinical Study IdentifierNCT03774875
SponsorAmgen
Last Modified on26 January 2021

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