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

Phase 1

• 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-BE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-20
• Last Update Posted: 21 August 2017

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:
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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA;Secondary Objective: - Efficacy of secukinumab compared to etanercept in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA<br>- Clinical safety and tolerability of secukinumab compared to etanercept and placebo over 12 weeks<br>- Quality of life changes based on patient reported outcomes over 12 and 52 weeks;Primary end point(s): PASI and IGA;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - PASI and IGA<br>- Clinical safety and tolerability of secukinumab<br>- Quality of life changes;Timepoint(s) of evaluation of this end point: Respectively : <br>- 12 weeks<br>- 12 weeks<br>- 12 and 52 weeks