A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)
A 28-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous 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-3222-012)
This date has not been verified as actual or estimated.
Primary Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief Summary
This study is being conducted to evaluate the efficacy and safety/tolerability of SCH 900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
withdrawn
Actual enrollment (reported)
0 participants
Study completion date
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations
0 countries · 0 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
September 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 3, 2013
Actual (reported)
First Posted
September 6, 2013
Actual (reported)
Primary Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12
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
Baseline, Week 12
Secondary Outcomes (8)
Proportion of Participants Achieving PASI-90 Response at Week 12 and 28
Week 12, Week 28
Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12 and Week 28
Week 12, Week 28
Proportion of Participants With a DLQI Score of 0 or 1 at Week 12 and Week 28
Week 12, Week 28
Mean Change and Mean Percent Change from Baseline in PASI Score Over Time
Baseline, Up to Week 28
Mean Change From Baseline in the Nail Area Psoriasis Severity Index (NAPSI) at Week 12 and Week 28
Week 12, Week 28
+3 more secondary outcomes
Study Arms (4)
MK-3222 200 mg + Placebo to Etanercept
EXPERIMENTAL
MK-3222 200 mg subcutaneously (SC) on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28.
Drug: MK-3222 200 mgDrug: Placebo to Etanercept
MK-3222 100 mg + Placebo to Etanercept
EXPERIMENTAL
MK-3222 100 mg SC on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28.
Placebo to MK-3222 administered SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12, then once weekly up to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive MK-3222 high dose or MK-3222 low dose on Weeks 12, 16, and 28 and, optionally, every 12 weeks thereafter through Week 220.
Drug: Placebo to MK-3222Drug: Placebo to Etanercept
Placebo to MK-3222 + Etanercept 50 mg
ACTIVE COMPARATOR
Matching placebo to MK-3222 SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and then once weekly through Week 28.
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 2 of the base study
For the extension study: must have achieved at least a PASI-50 response by the end of Part 2 of the base study
You may not qualify if:
Non-plaque forms of psoriasis
Presence or history of severe psoriatic arthritis that is well-controlled on current treatment regimen
Women of childbearing potential that are pregnant, intend to become pregnant, or are lactating
Participant is expected to require topical therapy, phototherapy, or systemic therapy
Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
Previous use of MK-3222/SCH 900222, or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including P40, P19, and IL-17 antagonists, or etanercept
Latex allergy or sensitivity
Active or untreated latent tuberculosis (TB)
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
Contact the study team to confirm eligibility.
Receptors, Cytokine
Receptors, Immunologic
Receptors, Cell Surface
Membrane Proteins
Primary Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 24, 2022
Record last verified: 2022-02
Source record
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Source: ClinicalTrials.gov.
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