A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-25

Study Completion Date

2012-10-24

Brief Summary

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This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

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Detailed Description

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Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Tildrakizumab 5 mg

Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 1: Tildrakizumab 25 mg

Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 1: Tildrakizumab 100 mg

Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 1: Tildrakizumab 200 mg

Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 1: Placebo

Participants receive placebo, SC, at Weeks 0 and 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC administration of Placebo

Part 2: Tildrakizumab 5 mg

Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 2: Tildrakizumab 25 mg

Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 2: Tildrakizumab 100 mg

Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 2: Tildrakizumab 200 mg

Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks

Group Type EXPERIMENTAL

tildrakizumab

Intervention Type BIOLOGICAL

SC administration of tildrakizumab at assigned dose

Part 3: Tildrakizumab 5 mg Follow-up

Participants are followed for up to 20 weeks after the last dose of study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 3: Tildrakizumab 25 mg Follow-up

Participants are followed for up to 20 weeks after the last dose of study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 3: Tildrakizumab 100 mg Follow-up

Participants are followed for up to 20 weeks after the last dose of study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 3: Tildrakizumab 200 mg Follow-up

Participants are followed for up to 20 weeks after the last dose of study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 3: Placebo Follow-up

Participants are followed for up to 20 weeks after the last dose of study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tildrakizumab

SC administration of tildrakizumab at assigned dose

Intervention Type BIOLOGICAL

Placebo

SC administration of Placebo

Intervention Type DRUG

Other Intervention Names

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SCH 900222 MK-3222

Eligibility Criteria

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Inclusion Criteria

* Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[BSA\] involvement, "moderate" or greater score on the Physician's Global Assessment \[PGA\] scale, and PASI score ≥12 at Baseline)
* Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study

Exclusion Criteria

* Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Participants who will require oral or injectable corticosteroids during the trial
* Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
* Participants 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 treatment with study medication)
* Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
* Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No