A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: PPC-06 400 mg QD; PPC-06 400 mg BID; PPC-06 600 mg; Placebo
Intervention description: Tepilamide Fumarate 400 mg tablet once per day; Tepilamide Fumarate tablets 400 mg twice per day; Tepilamide Fumarate tablets 600 mg twice per day; white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess
      the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with
      moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy males or non-pregnant females age ≥18 years at the time of screening
             (or who have reached the state minimum legal age of consent).

          -  Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to
             randomization (no morphology changes or significant flares of disease activity in the
             last 6 months in the opinion of the investigator or as reported by the subject).

          -  Severity of disease meeting all 3 of the following criteria prior to randomization (at
             the Baseline [Day 0] visit):

               1. PASI score of ≥12

               2. Total body surface area (BSA) affected by plaque psoriasis of ≥10%

               3. IGA score of >3

          -  Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

        Exclusion Criteria:

          -  Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic,
             predominantly guttate, or pustular psoriasis).

          -  Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that
             has not resolved within 4 weeks prior to screening.

          -  Subjects who have received systemic non-biologic psoriasis therapy or phototherapy
             (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy,
             ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4
             weeks prior to the Baseline Visit.

          -  Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the
             Baseline Visit.

          -  Subjects with history of concurrent or recent use of any biologic agent within the
             following washout periods prior to baseline visit:

               -  Etanercept - 35 days

               -  Infliximab, adalimumab - 12 weeks

               -  Ustekinumab - 24 weeks

               -  Any other biologic agent <5 half-lives prior to the Baseline Visit

          -  Subjects with history of use of any investigational drug within 28 days prior to
             randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).