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A Study to Assess the Effect of Ustekinumab (Stelara�) and Etanercept (Enbrel�) in Participants With Moderate to Severe Psoriasis (MK-0000-206)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Ustekinumab (Drug); Etanercept (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the acquisition, handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on biomarkers in lesional skin in participants with moderate to severe psoriasis will be evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma (IFN-γ).

Clinical Details

Official title: A Clinical Trial to Assess the Effects of Ustekinumab and Etanercept on Skin and Blood Biomarkers of Psoriasis in Patients With Moderate to Severe Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab

Secondary outcome:

Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab

Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Is unlikely to conceive (for female participants of reproductive potential)- Part 2

- Has a diagnosis of predominantly plaque psoriasis for ≥ 6 months-Parts 1 and 2

- Has a plaque-type psoriatic lesion with a Target Lesion Score (TLS) score of ≥ 6 in a

hidden area of the body such as the abdomen, thighs, lower back or buttock that is suitable for biopsy- Part 1

- Is considered to be a candidate for phototherapy or systemic therapy - Part 2

- Has a Psoriasis Area and Severity Index (PASI) score ≥ 12 at Baseline - Part 2

- Has psoriasis body surface area (BSA) involvement ≥ 10% at Baseline - Part 2

- Has a Physician's Global Assessment (PGA) of at least moderate disease (moderate,

marked, or severe) at Baseline - Part 2

- Is considered to be eligible according to the tuberculosis (TB) screening criteria -

Part 2 Exclusion Criteria:

- Has nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly

pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or

new onset guttate psoriasis - Parts 1 and 2

- Women of childbearing potential who are pregnant, intend to become pregnant (within 6

months of completing the trial), or are lactating - Parts 1 and 2

- Has a history of neoplastic disease or concurrent malignancy - Part 2

- Requires oral or injectable corticosteroids during the trial - Part 2

- Have any infection requiring treatment with antibiotics within 2 weeks prior to

screening or serious infection requiring hospitalization or treatment with IV

antibiotics within 8 weeks prior to screening - Part 2

- Has a positive human immunodeficiency virus (HIV) test result, hepatitis B surface

antigen, or hepatitis C test result - Part 2

- Has received live virus vaccination within 4 weeks prior to screening or who intends

to receive live virus vaccination during the trial - Part 2

- Has previous exposure to any agents targeting IL-12 and/or IL-23 (e. g. ustekinumab) -

Part 2

- Has prior exposure tumor necrosis factor (TNF) antagonists (e. g. infliximab,

etanercept, golimumab, adalimumab) and discontinued due to lack of efficacy or for

adverse effects - Part 2

- Has been treated with any medications that are associated with Progressive Multifocal

Leukoencephalopathy (PML), such as efalizumab (Raptiva) or natalizumab (Tysabri) -

Part 2

- Has taken any immunosuppressive agents (e. g. corticosteroids, methotrexate,

azathioprine, cyclosporine) for treatment of conditions other than for Psoriasis

within 4 weeks of screening - Part 2

- Is currently taking any of the prohibited medications and is unwilling to washout of

the medication(s) for the indicated timeframe prior to screening and for the duration

of the study - Part 2

Locations and Contacts

Additional Information

Starting date: March 2011
Last updated: January 13, 2015

Page last updated: August 23, 2015

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