Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Apremilast, oral, twice daily; Placebo, oral, twice daily
Intervention MeSH terms: Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 595.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3; Double-Blind; Efficacy; Safety; Apremilast; Otezla; CC-10004; Plaque Psoriasis; Mild; Moderate; Scalp; Nail; Itch

Summary:

      This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed
      to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to
      moderate plaque psoriasis.

      Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to
      receive either apremilast 30 mg BID or placebo for the first 16 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Subject must be male or female, ≥18 years of age at the time of signing the informed
             consent form (ICF).

          2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior
             to signing the ICF.

          3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening
             and Baseline.

          4. Subject must be inadequately controlled with or intolerant of at least one topical
             therapy at both Screening and Baseline.

          5. Subject must be in good health (except for psoriasis) as judged by the investigator,
             based on medical history, physical examination, clinical laboratories, and urinalysis.

          6. Subject must meet laboratory criteria.

          7. Subject has not had prior exposure to biologics for the treatment of psoriatic
             arthritis or psoriasis, or any other condition that could impact the assessment of
             psoriasis.

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          1. Subject has any significant medical condition, laboratory abnormality, or psychiatric
             illness that would prevent the subject from participating in the study.

          2. Subjects has any condition, including the presence of laboratory abnormalities, which
             would place the subject at unacceptable risk if he/she were to participate in the
             study.

        2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active
        tuberculosis (TB) or a history of incompletely treated TB.

        4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or
        acquired immunodeficiency (eg, common variable immunodeficiency disease).

        5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at
        Screening.

        6. Subject has prior history of suicide attempt at any time in the subject's life time or
        major psychiatric illness requiring hospitalization within the last 3 years prior to
        signing the informed consent. 7. Subject has current or planned concurrent use of therapies
        that may have a possible effect on psoriasis during the course of the treatment phase of
        the trial.

        8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5
        pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

        9. Subject had prior treatment with apremilast.