Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis assessing different doses and dose regimens

A randomized, double-blind, multicenter study of subcutaneous secukinumab, assessing Psoriasis Area and Severity Index (PASI) response and maintenance of response in subjects with moderate to severe chronic plaque-type psoriasis on either a fixed dose regimen or on a retreatment at start of relapse regimen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000767-27-GB

Enrollment

918

Registered

2011-05-27

Start date

2011-07-25

Completion date

Unknown

Last updated

2013-06-17

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/infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Moderate and severe plaque-type psoriasis diagnosed for at least 6 months. • Severity of disease meeting all of the following three criteria: o PASI score of 12 or greater, o Investigator’s Global Assessment (IGA) score of 3 or greater o Total body surface area (BSA) affected of 10% or greater. • Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy. 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 872 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: • Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). • Current drug-induced psoriasis. • Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor. • Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject. • Hematological abnormalities. • History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. • History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. • Pregnant or nursing (lactating) women. Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of secukinumab over 52 weeks based on PASI, in two different doses and two treatment regimens (fixed interval vs personalized treatment), in subjects with moderate to severe chronic plaque-type psoriasis;Secondary Objective: - Efficacy of assessed secukinumab doses and dose regimens over time and up to 52 weeks based on PASI and IGA - Safety and tolerability of assessed secukinumab doses and dose regimens over time and up to 52 weeks - Quality of life changes based on patient reported outcomes over time and up to 52 weeks for the assessed secukinumab doses and dose regimens ;Primary end point(s): PASI 75 response;Timepoint(s) of evaluation of this end point: Week 40 to Week 52	—

Measure

Time frame

Main Objective: Efficacy of secukinumab over 52 weeks based on PASI, in two different doses and two treatment regimens (fixed interval vs personalized treatment), in subjects with moderate to severe chronic plaque-type psoriasis;Secondary Objective: - Efficacy of assessed secukinumab doses and dose regimens over time and up to 52 weeks based on PASI and IGA - Safety and tolerability of assessed secukinumab doses and dose regimens over time and up to 52 weeks - Quality of life changes based on patient reported outcomes over time and up to 52 weeks for the assessed secukinumab doses and dose regimens ;Primary end point(s): PASI 75 response;Timepoint(s) of evaluation of this end point: Week 40 to Week 52

—

Secondary

Measure	Time frame
Secondary end point(s): - PASI and IGA - Safety and tolerability - Quality of Life changes ;Timepoint(s) of evaluation of this end point: Respectively: - 52 weeks - Over time and up to Week 52 - Over time and up to Week 52	—

Countries

Austria, Bulgaria, Canada, Czech Republic, Germany, India, Italy, Japan, Peru, Poland, Singapore, Switzerland, Taiwan, United Kingdom, United States, Vietnam

Contacts

Public ContactMedical Information Services

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com+4401276698370

Outcome results

None listed

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