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A Study of the Safety and Efficacy of CNTO 1275 in Subjects With Severe Plaque-Type Psoriasis

2014-08-27 03:44:57 | BioPortfolio

Summary

The primary objective of this study is to evaluate the efficacy and safety initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Description

Although numerous therapeutic options exist for the treatment of psoriasis, significant unmet medical needs for effective therapies with limited toxicity and side effects. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that CNTO 1275 will be more effective in treatment of psoriasis than placebo, and that the improvement in psoriasis will result in an improved quality of life for treated patients.

The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Psoriasis

Intervention

CNTO 1275

Status

Completed

Source

Centocor, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:57-0400

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The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at...

A Study of the Safety and Efficacy of CNTO 1275 in Patients With Severe Plaque-Type Psoriasis

The primary purpose of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

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The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with moderate to severe plaque psoriasis.

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PubMed Articles [384 Associated PubMed Articles listed on BioPortfolio]

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Imbalances of T cell subsets are hallmarks of disease-specific inflammation in psoriasis. However, the relevance of B cells for psoriasis remains poorly investigated.

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Medical and Biotech [MESH] Definitions

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

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