Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (FIXTURE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Placebo; Drug: etanercept; Drug: secukinumab (AIN457)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358578

CAIN457A2303

2010-022228-66

Details and patient eligibility

About

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Enrollment: 1,306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

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 (interleukin 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 inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,306 participants in 6 patient groups, including a placebo group

AIN457 150mg

Experimental group

Description:

AIN457 150mg

Treatment:

Drug: Placebo

Drug: secukinumab (AIN457)

AIN457 300mg

Experimental group

Description:

AIN457 300mg

Treatment:

Drug: Placebo

Drug: secukinumab (AIN457)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Etanercept

Active Comparator group

Description:

Etanercept

Treatment:

Drug: etanercept

Drug: Placebo

AIN457 150mg from Placebo

Experimental group

Description:

Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase

Treatment:

Drug: Placebo

Drug: secukinumab (AIN457)

AIN457 300mg from Placebo

Experimental group

Description:

Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase

Treatment:

Drug: Placebo

Drug: secukinumab (AIN457)