Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023512-13-LV

Enrollment

720

Registered

2011-04-04

Start date

2011-05-24

Completion date

Unknown

Last updated

2013-07-15

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 Current Sponsor code: AIN457 Concentration unit: mg milligram(s)

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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 685 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - Current 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 secukinumab or any other drug that targets 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, or a condition that significantly immunocompromises the subject. - History of an ongoing, chronic or recurrent infection or evidence of untreated tuberculosis Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA;Secondary Objective: - Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis over 52 weeks based on PASI and IGA - Clinical safety and tolerability of secukinumab over 12 and 52 weeks - Quality of life assessments 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 in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA;Secondary Objective: - Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis over 52 weeks based on PASI and IGA - Clinical safety and tolerability of secukinumab over 12 and 52 weeks - Quality of life assessments 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 - Patient reported outcomes;Timepoint(s) of evaluation of this end point: Respectively: - 52 weeks - 12 and 52 weeks - 12 and 52 weeks	—

Countries

Argentina, Canada, Colombia, Estonia, Iceland, Israel, Japan, Latvia, Lithuania, Mexico, Panama, Peru, Russian Federation, Taiwan, United States

Contacts

Public ContactFlorent Hartmann

Novartis Pharma AG

florent.hartmann@novartis.com0041616964466

Outcome results

None listed

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