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: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-022228-66-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-31
• 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