An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Oral; Oral
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: 289.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Genital Psoriasis; CC-10004; Apremilast; Plaque Psoriasis

Summary:

      This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to
      evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital
      psoriasis (modified sPGA-G ≥3, moderate or severe).

      Approximately 286 subjects with moderate to severe genital 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 is ≥ 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 moderate or severe psoriasis of the genital area at
             Screening and Baseline.

          4. Subject must have a diagnosis of moderate or severe psoriasis at Screening and
             Baseline.

          5. Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening
             and Baseline.

          6. Subject must have been inadequately controlled with or intolerant of topical therapy,
             or topical therapy is inappropriate for the treatment of psoriasis affecting the
             genital area.

          7. Subject must be in good health (except for psoriasis) as judged by the investigator,
             based on medical history, physical examination, clinical laboratories, and urinalysis.

          8. Subject must meet laboratory criteria

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          1. Subject has any significant medical condition or laboratory abnormality, that would
             prevent the subject from participating in the study.

          2. Subject has any condition including the presence of laboratory abnormalities, which
             places the subject at unacceptable risk if he/she were to participate in the study.

          3. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at
             Screening.

          4. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

          5. Subject has prior history of suicide attempt at any time in the subject's life time
             prior to signing the informed consent and randomization, or major psychiatric illness
             requiring hospitalization within the last 3 years prior to signing the informed
             consent.

          6. Subject has current or planned therapies that may have a possible effect on psoriasis
             of the body and/or genital area during the course of the treatment phase of the trial

          7. Subject had prior treatment with apremilast.