A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tildrakizumab 200 mg; Tildrakizumab 100 mg; Tildrakizumab Placebo; Etanercept Placebo; Etanercept 50 mg
Intervention description: Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.; Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.; Matching placebo to tildrakizumab administered SC; Matching placebo to etanercept administered SC; Etanercept 50 mg administered SC
Intervention MeSH terms: Etanercept; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1090.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the efficacy and safety/tolerability of
      tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe
      plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to
      placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the
      proportion of participants achieving >= Psoriasis Area Sensitivity Index of 75% (PASI-75)
      response and the proportion of participants with a Physician's Global Assessment (PGA) score
      of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior
             to enrollment;

          -  Candidate for phototherapy or systemic therapy;

          -  Premenopausal female participants must agree to abstain from heterosexual activity or
             use a medically approved method of contraception or use appropriate effective
             contraception as per local regulations or guidelines

          -  For the extension study: must have completed Part 3 of the base study

          -  For the extension study: must have achieved at least a PASI-50 response by the end of
             Part 3 of the base study

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis

          -  Presence or history of severe psoriatic arthritis and is well-controlled on current
             treatment regimen

          -  Women of childbearing potential who are pregnant, intend to become pregnant, or are
             lactating

          -  Participant is expected to require topical therapy, phototherapy, or systemic therapy
             during the trial

          -  Presence of any infection or history of recurrent infection requiring treatment with
             systemic antibiotics

          -  Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23
             (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17
             antagonists

          -  Latex allergy or sensitivity

          -  Active or untreated latent tuberculosis (TB)

          -  For the extension study: women of child-bearing potential who are pregnant, intend to
             become pregnant within 6 months of completing the trial, or are breast feeding

          -  For the extension study: active or uncontrolled significant organ dysfunction or
             clinically significant laboratory abnormalities

          -  For the extension study: expected to require topical treatment, phototherapy, or
             systemic treatment during the extension study