Assessment of Efficacy and Safety of Secukinumab in Adult Patients in Turkish Population

Summary

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.

Conditions

• Psoriasis

Interventions

DRUG

"Secukinumab" "Cosentyx TM"

"Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Nilgun Atakan, Prof.Dr · Hacettepe University Medical Faculty

• Server Serdaroglu, Prof.Dr · Istanbul University Cerrahpasa Medical Faculty

• Emel Bulbul Baskan, Prof.Dr · Uludag University Medical Faculty

• Erkan Alpsoy, Prof.Dr · Akdeniz University Medical Faculty

• Ferda Artuz, Prof.Dr · Ankara City Hospital Bilkent

• Guliz Ikizoglu, Prof.Dr · Mersin University Medical Faculty

• Guzin Ozarmagan, Prof.Dr · Istanbul University Istanbul Medical Faculty

• Ilgen Ertam, Prof.Dr · Ege University Medical Faculty

• Murat Borlu, Prof.Dr · Erciyes University Medical Faculty

• Muzeyyen Sanlı Gonul, Ass.Prof · Dıskapi Training and Research Hospital

• Nilgun Senturk, Prof.Dr · Ondokuz Mayıs University Medical Faculty

• Savas Yaylı, Ass.Prof · Karadeniz Technical University

• Serhat Inaloz, Prof.Dr. · Gaziantep University Medical Faculty

• Sinan Dogan, Spec.Dr · Bozyaka Training and Research Hospital

• Tulin Ergun, Prof.Dr · Marmara university Medical Faculty

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-03-31

Completion

2017-03-31