A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants … (NCT01936688) | Clinical Trial Compass
WithdrawnPhase 3
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)
0Started 2013-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria:
* 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 uncontrolle…
What they're measuring
1
Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12
Timeframe: Week 12
2
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