Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
Phase 3
Withdrawn
- Conditions
- Psoriasis
- Interventions
- Biological: Intervention BBiological: Intervention ABiological: Placebo
- Registration Number
- NCT01900782
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Chronic plaque-type psoriasis, moderate to severe
- Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type
- Ongoing use of treatments not allowed for psoriasis
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator Intervention B Subcutaneous injection Dosing Regimen 1 Intervention A Subcutaneous injection Placebo Placebo Subcutaneous injection Dosing Regimen 2 Intervention A Subcutaneous injection
- Primary Outcome Measures
Name Time Method PASI (psoriasis area and severity index) and IGA (investigator's global assessment) Week 12
- Secondary Outcome Measures
Name Time Method Patient reported outcome questionnaires Week 12 and 52 PASI (psoriasis area and severity index) and IGA (investigator's global assessment) Week 52 Vital signs, laboratory values, electrocardiograms (ECG), adverse events Week 12 and 52