A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tildrakizumab 200 mg; Tildrakizumab 100 mg; Matching Placebo
Intervention description: Two tildrakizumab 100 mg/mL pre-filled syringes (PFS); Tildrakizumab 100 mg/mL PFS; Matching placebo to tildrakizumab PFS
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 772.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the efficacy and safety/tolerability of
      subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension
      study, in participants with moderate-to-severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior
             to study enrollment

          -  A candidate for phototherapy or systemic therapy

          -  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

          -  For the extension study: must have received active tildrakizumab (MK-3222) treatment
             within 12 weeks prior to the end of Part 3 of the base study

          -  Premenopausal female participants must agree to abstain from heterosexual activity or
             use a medically accepted method of contraception or use appropriate effective
             contraception as per local regulations or guidelines

          -  If enrolled at a Japanese site, participants with psoriatic arthritis using
             non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4
             weeks prior to the first dose of study drug and must not be expected to require an
             increase in dose over the course of the study

        Exclusion Criteria:

          -  Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or
             medication-exacerbated psoriasis, or new onset guttate psoriasis

          -  Current or history of severe psoriatic arthritis and is well-controlled on current
             treatment

          -  Women of child-bearing potential who are pregnant, intend to become pregnant within 6
             months of completing the trial, or who are breast feeding

          -  Expected to require topical treatment, phototherapy, or systemic treatment during the
             trial

          -  Presence of any infection

          -  History of recurrent infection requiring treatment with systemic antibiotics within 2
             weeks of screening

          -  Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors
             including P40, p19, and IL-17 antagonists

          -  Evidence of active or untreated latent tuberculosis (TB)

          -  Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
             (HBsAg) or hepatitis C virus (HCV)

          -  At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV)
             deoxyribonucleic acid (DNA)

          -  At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA

          -  For the extension study: women of child-bearing potential who are pregnant, intend to
             become pregnant within 6 months of completing the trial, or who 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

          -  At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the
             screening visit.