Title
Assessment of Efficacy and Safety of Secukinumab in Adult Patients in Turkish Population
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
Phase
Phase 3Lead Sponsor
NovartisStudy Type
InterventionalStatus
WithdrawnIndication/Condition
PsoriasisIntervention/Treatment
secukinumab ...Study Participants
0Secukinumab 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)
"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
"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
Inclusion Criteria: Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator Diagnosis of chronic plaque psoriasis for at least 6 months before enrollment Patients who were evaluated as candidates for systemic therapy, defined as having psoriasis intolerant or /and inadequately controlled by: topical treatment (including topical corticosteroid) and/or phototherapy and/or any previous systemic treatment for psoriasis or any previous treatment with biologic agents Exclusion Criteria: Forms of psoriasis other than plaque psoriasis Drug-induced psoriasis Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA Pregnant or nursing (lactating) women Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) Pre-existing or recent-onset central or peripheral nervous system demyelinating disorders Significant medical problems, including but not limited to the following: uncontrolled hypertension, congestive heart failure Active systemic infections during the 2 weeks prior to enrollment History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to enrollment History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to enrollment Plans for administration of live vaccines during the study period or in the 6 weeks prior to enrollment Not willing to limit UV light exposure
