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)

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.; Sun Pharmaceutical Industries Limited
• Treatments: Antibodies, Monoclonal; Etanercept

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