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)
3 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2013
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 3, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedFebruary 24, 2022
February 1, 2022
4.9 years
September 3, 2013
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
EXPERIMENTALMK-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.
MK-3222 100 mg + Placebo to Etanercept
EXPERIMENTALMK-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 + Placebo to Etanercept
PLACEBO COMPARATORPlacebo 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.
Placebo to MK-3222 + Etanercept 50 mg
ACTIVE COMPARATORMatching 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.
Interventions
Matching placebo to MK-3222 administered SC.
Matching placebo to etanercept for subcutaneous injection.
Etanercept 50 mg for subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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 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.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2013
First Posted
September 6, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
February 24, 2022
Record last verified: 2022-02