Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Etanercept; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/ mL
Route of Administration: Subcutaneous use; Active Substance: Etanercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 50 mg / mL
Route of Administration: Subcutaneous use; Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Intervention MeSH terms: Etanercept; Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 559.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Psoriasis

Summary:

      The purpose of this study is to investigate the efficacy and safety of two dose levels of
      certolizumab pegol compared to active comparator and placebo in adults with moderate to
      severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided informed consent

          -  Adult men or women >= 18 years

          -  Chronic plaque psoriasis for at least 6 months

          -  Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and
             Physician's Global Assessments score >= 3

          -  Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Erythrodermic, guttate, generalized pustular form of psoriasis

          -  History of current, chronic, or recurrent infections of viral, bacterial, or fungal
             origin as described in the protocol

          -  Congestive heart failure

          -  History of a lymphoproliferative disorder including lymphoma or current signs and
             symptoms suggestive of lymphoproliferative disease

          -  Concurrent malignancy or a history of malignancy as described in the protocol

          -  History of, or suspected, demyelinating disease of the central nervous system (e.g.,
             multiple sclerosis or optic neuritis)

          -  Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
             study or within 5 months following last dose of study drug in the UK, Czech Republic,
             Germany, and France, and within 3 months for all other countries. Male subjects who
             are planning a partner pregnancy during the study or within 5 months following the
             last dose in France and within 10 weeks in all other countries

          -  Any other condition which, in the Investigator's judgment, would make the subject
             unsuitable for participation in the study

          -  Other protocol-defined exclusion criteria may apply