Psoriasis Clinical Trial
Official title:
A 16-week, Single Arm, Multicenter Study for the Assessment of Efficacy and Safety of Secukinumab in aduLt Patients With Moderate to Severe plaquE Psoriasis in Turkish Population
Secukinumab targets a different interleukin and has potential to be used as alternative to existing treatments. This study will provide clinical data with respect to efficacy through Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and evaluate the impact of the treatment on quality of life and work productivity in subjects with moderate to severe plaque psoriasis in the Turkish population.
To demonstrate the efficacy of secukinumab in subjects with moderate to severe plaque psoriasis based on the percentage of PASI 90 responder patients at Week 16 as compared to baseline Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4 The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16 Work productivity (measured with WPAI-PSO) at Week 16 Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16 Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA) ;
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