Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects with Moderate to Severe, Chronic Plaque-Type Psoriasis

• Conditions: Moderate to severe chronic plaque-type psoriasis; MedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1Level: LLTClassification code 10050577Term: Psoriatic plaqueSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-022228-66-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1264

Inclusion Criteria

• Subjects with chronic, plaque-type psoriasis for at least 6 months • Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area • Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies) Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1201
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

• Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis) • Drug induced psoriasis • Use of other psoriasis treatments during the study • Prior use of etanercept • Prior use of secukinumab or any other drug that target IL-17 or the IL- 17 receptor • Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment • Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc. • History of an ongoing, chronic or recurrent infection or evidence of tuberculosis • Allergy to rubber or latex Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified