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Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

2015-03-10 01:53:23 | BioPortfolio

Summary

This is an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) will be eligible to join this extension study. This extension study is planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab will be used.

Study Design

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

Conditions

Moderate to Severe Plaque-type Psoriasis

Intervention

Secukinumab (AIN457), Placebo

Location

Novartis Investigative Site
Birmingham
Alabama
United States
35205

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-10T01:53:23-0400

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PubMed Articles [14642 Associated PubMed Articles listed on BioPortfolio]

Adverse drug events observed with 150 mg versus 300 mg secukinumab for the treatment of moderate to severe plaque psoriasis: A systematic review and meta-analysis.

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Medical and Biotech [MESH] Definitions

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.

A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.

A narcotic antagonist with analgesic properties. It is used for the control of moderate to severe pain.

Endovascular procedure in which atheromatous plaque is excised by a cutting or rotating catheter. It differs from balloon and laser angioplasty procedures which enlarge vessels by dilation but frequently do not remove much plaque. If the plaque is removed by surgical excision under general anesthesia rather than by an endovascular procedure through a catheter, it is called ENDARTERECTOMY.

An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097)

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