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

• 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: EUCTR2011-000767-27-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-23
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 918

Inclusion Criteria

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months; • Severity of disease meeting all of the following three criteria: -PASI score of 12 or greater, -Investigator's Global Assessment (IGA) score of 3 or greater, - 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

• 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.

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 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 Outcome Measures

Name	Time	Method
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.