A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab; Etanercept
Intervention description: Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16; Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
Intervention MeSH terms: Etanercept; Ustekinumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: psoriasis; Ustekinumab; Stelara; Etanercept; Enbrel

Summary:

      This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the
      acquisition, handling and shipping procedure for skin biopsies obtained from participants
      with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In
      Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on
      biomarkers in lesional skin in participants with moderate to severe psoriasis will be
      evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe
      psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The
      primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression
      of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma
      (IFN-γ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is unlikely to conceive (for female participants of reproductive potential)- Part 2

          -  Has a diagnosis of predominantly plaque psoriasis for ≥ 6 months-Parts 1 and 2

          -  Has a plaque-type psoriatic lesion with a Target Lesion Score (TLS) score of ≥ 6 in a
             hidden area of the body such as the abdomen, thighs, lower back or buttock that is
             suitable for biopsy- Part 1

          -  Is considered to be a candidate for phototherapy or systemic therapy - Part 2

          -  Has a Psoriasis Area and Severity Index (PASI) score ≥ 12 at Baseline - Part 2

          -  Has psoriasis body surface area (BSA) involvement ≥ 10% at Baseline - Part 2

          -  Has a Physician's Global Assessment (PGA) of at least moderate disease (moderate,
             marked, or severe) at Baseline - Part 2

          -  Is considered to be eligible according to the tuberculosis (TB) screening criteria -
             Part 2

        Exclusion Criteria:

          -  Has nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly
             pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new
             onset guttate psoriasis - Parts 1 and 2

          -  Women of childbearing potential who are pregnant, intend to become pregnant (within 6
             months of completing the trial), or are lactating - Parts 1 and 2

          -  Has a history of neoplastic disease or concurrent malignancy - Part 2

          -  Requires oral or injectable corticosteroids during the trial - Part 2

          -  Have any infection requiring treatment with antibiotics within 2 weeks prior to
             screening or serious infection requiring hospitalization or treatment with IV
             antibiotics within 8 weeks prior to screening - Part 2

          -  Has a positive human immunodeficiency virus (HIV) test result, hepatitis B surface
             antigen, or hepatitis C test result - Part 2

          -  Has received live virus vaccination within 4 weeks prior to screening or who intends
             to receive live virus vaccination during the trial - Part 2

          -  Has previous exposure to any agents targeting IL-12 and/or IL-23 (e.g. ustekinumab) -
             Part 2

          -  Has prior exposure tumor necrosis factor (TNF) antagonists (e.g. infliximab,
             etanercept, golimumab, adalimumab) and discontinued due to lack of efficacy or for
             adverse effects - Part 2

          -  Has been treated with any medications that are associated with Progressive Multifocal
             Leukoencephalopathy (PML), such as efalizumab (Raptiva) or natalizumab (Tysabri) -
             Part 2

          -  Has taken any immunosuppressive agents (e.g. corticosteroids, methotrexate,
             azathioprine, cyclosporine) for treatment of conditions other than for Psoriasis
             within 4 weeks of screening - Part 2

          -  Is currently taking any of the prohibited medications and is unwilling to washout of
             the medication(s) for the indicated timeframe prior to screening and for the duration
             of the study - Part 2