Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments mk-3222 200 mg, mk-3222 100 mg, matching placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date December 2012
End date June 2014
Trial size 772 participants
Trial identifier NCT01722331, 132284, 2012-002255-42, 3222-010, P07770

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator
Arm
(Experimental)
MK-3222 administered subcutaneously (SC) at a dose of 200 mg at Week 0 and Week 4, and then every 12 weeks until study end or participant discontinuation.
mk-3222 200 mg SCH 900222
(Experimental)
MK-3222 administered SC at a dose of 100 mg at Week 0 and Week 4, and then every 12 weeks until study end or participant discontinuation.
mk-3222 100 mg SCH 900222
(Placebo Comparator)
Matching placebo administered SC at Week 0 and Week 4.
matching placebo

Primary Outcomes

Measure
Proportion of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12
time frame: Week 12
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
time frame: Week 12
Number of Participants Experiencing Adverse Events (AEs) Across Study
time frame: Up to Week 276
Number of Participants Discontinuing Due to Drug-Related AEs Up to Week 12 and Across Study
time frame: Up to Week 12; Up to Week 276
Number of Participants Experiencing an AE Up to Week 12
time frame: Up to Week 12
Number of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 and Across Study
time frame: Up to Week 12; Up to Week 276

Secondary Outcomes

Measure
Proportion of Participants With PASI-90 Response At Week 12
time frame: Week 12
Proportion of Participants With PASI-100 Response at Week 12
time frame: Week 12
Change From Baseline in the Participant Dermatology Life Quality Index (DLQI) at Week 12
time frame: Baseline, Week 12
Proportion of Participants With DLQI Score of 0 or 1 at Week 12
time frame: Week 12

Eligibility Criteria

All participants at least 18 years old.

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 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 that are pregnant, intend to become pregnant within 6 months of completing the trial, or that 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 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 (HBs Ag) 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 that are pregnant, intend to become pregnant within 6 months of completing the trial, or that 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.

Additional Information

Official title A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..