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)

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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.