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

A randomized, double-blind, double-dummy, placebo controlled, multicenter study of subcutaneous secukinumab to demonstrate efficacy after twelve weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis. - FIXTURE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022228-66-DE

Enrollment

1264

Registered

2011-03-31

Start date

2011-08-03

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe chronic plaque-type psoriasis MedDRA version: 14.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Secukinumab CAS Number: 875356-43-7 Current Sponsor code: AIN457 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 - Clinical safety and tolerability of secukinumab compared to etanercept and placebo over 12 weeks - 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	—

Measure

Time frame

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 - Clinical safety and tolerability of secukinumab compared to etanercept and placebo over 12 weeks - 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

Measure	Time frame
Secondary end point(s): - PASI and IGA - Clinical safety and tolerability of secukinumab - Quality of life changes;Timepoint(s) of evaluation of this end point: Respectively : - 12 weeks - 12 weeks - 12 and 52 weeks	—

Countries

Argentina, Australia, Brazil, Canada, Colombia, Finland, Germany, Guatemala, Hungary, Iceland, India, Italy, Korea, Republic of, Peru, Poland, Russian Federation, Singapore, Spain, Sweden, Turkey, United Kingdom, United States, Venezuela, Bolivarian Republic of

Contacts

Public ContactMedical Competence Center

Novartis Pharma GmbH

infoservice.novartis@novartis.com00491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026