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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
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

Male or female 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 October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..