A 52-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-3222-011)

A 52-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-3222-011) - reSURFACE-11

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50707

Enrollment

Registered

2013-04-03

Start date

2013-12-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

plaque psoriases psoriasis vulgaris

Interventions

Base Study Part 1: Weeks 0 to 12, Visits 2-6 • Arm A: MK-3222 200 mg SC at Weeks 0 and 4 AND etanercept placebo twice weekly (n=300) • Arm B: MK-3222 100 mg SC at Weeks 0 and 4 AND etanercept placeb

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subjects (>=18 years of age) with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis (defined by >=10% body surface area [BSA] involvement, PGA score >=3, and PASI score >=12 at Baseline [Visit 2]), - Subjects must have a diagnosis of predominantly plaque psoriasis for >=6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator), - Subjects must be considered candidates for phototherapy or systemic therapy.

Exclusion criteria

Exclusion criteria: - Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis., - Subject with current, or history of, severe psoriatic arthritis and is well-controlled on current therapy., - Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial) or are lactating., - Subject who is expected to require topical therapy, phototherapy, or systemic therapy during the trial., - Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening., - Subject with any previous use of etanercept, MK-3222 or other IL-23/Th-17 pathway inhibitors, including p40, p19, and IL-17 antagonists., - Subject is sensitive or allergic to latex., - Subject with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to first administration of study medication.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint • Proportion of subjects with PASI 75 response at Week 12 • Proportion of subjects with a PGA score of clear or minimal with at least a 2 grade reduction from baseline at Week 12 See Protocol page 63	—

Secondary

Measure	Time frame
Key Secondary Efficacy Endpoints • Proportion of subjects with PASI 75 response at Week 28 • Proportion of subjects with a PGA score of clear or minimal with at least a 2 grade reduction from baseline at Week 28. See Protocol page 63	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)