A Study to Determine the Optimal Dose of SCH 900222 for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495 AM2) (MK-3222-003) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT01225731

Purpose

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). 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.

Condition	Intervention	Phase
Psoriasis	Biological: SCH 900222 Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous SCH 900222 in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Study P05495)

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of participants with a ≥75% improvement in PASI score from Baseline at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of participants with a ≥75% improvement in PASI score from Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Proportion of participants with Physician's Global Assessment (PGA) of "cleared" or"minimal" at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 5 mg SCH 900222 Part 1: 5 mg SCH 900222 subcutaneous (SC) at Weeks 0 and 4. Part 2: Non-Responders: 100 mg SCH 900222 SC at Week 16 and then once every 12 weeks. Responders: 5 mg SCH 900222 at Week 16 and then once every 12 weeks.	Biological: SCH 900222 SC administration of 5 mg of SCH 900222
Experimental: 25 mg SCH 900222 Part 1: 25 mg SCH 900222 subcutaneous (SC) at Weeks 0 and 4. Part 2: Non-Responders: 100 mg SCH 900222 SC at Week 16 and then once every 12 weeks. Responders: 25 mg SCH 900222 at Week 16 and then once every 12 weeks.	Biological: SCH 900222 SC administration of 25 mg SCH 900222
Experimental: 100 mg SCH 900222 Part 1: 100 mg SCH 900222 subcutaneous (SC) at Weeks 0 and 4. Part 2: Non-Responders: 200 mg SCH900222 SC at Week 16 and then once every 12 weeks. Responders: 100 mg or 25 mg SCH 900222 at Week 16 and then once every 12 weeks.	Biological: SCH 900222 SC administration of 100 mg SCH 900222
Experimental: 200 mg SCH 900222 Part 1: 200 mg SCH 900222 subcutaneous (SC) at Weeks 0 and 4. Part 2: Non-Responders: 200 mg SCH 900222 SC at Week 16 and then once every 12 weeks. Responders: 200 mg or 100 mg SCH 900222 at Week 16 and then once every 12 weeks.	Biological: SCH 900222 SC administration of 200 mg SCH 900222
Placebo Comparator: Placebo Part 1: Placebo SC at Weeks 0 and 4. Part 2: Non-Responders: 100 mg SCH 900222 SC at Week 16 and then once every 12 weeks. Responders: 25 mg SCH 900222 at Week 16 and then once every 12 weeks.	Biological: Placebo SC administration of Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01225731 History of Changes
Other Study ID Numbers:	P05495, 2009-017272-24, MK-3222-003
Study First Received:	October 7, 2010
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2012