Clinical trial NCT02795416: Assessment of Efficacy and Safety of Secukinumab in Adult Patients in Turkish Population
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: Moderate to severe plaque psoriasis, PASI, secukinumab, monoclonal antibody, Turkish population
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of PASI 90 responder patients at Week 16 as compared to baseline
timeFrame: 16 week
Secondary outcomes:
measure: Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4
timeFrame: 4 week
measure: The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16
timeFrame: 4 and 16 week
measure: Work productivity (measured with WPAI-PSO) at Week 16
timeFrame: 16 week
measure: Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: 16 week
measure: Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
timeFrame: 16 week
Other outcomes:
measure: In case of insulin resistance determined at the baseline, the change in the resistance level as measured by HOMA-IR
timeFrame: 16 week
Locations:
Study officials:
affiliation: Hacettepe University Medical Faculty
name: Nilgun Atakan, Prof.Dr
role: STUDY_DIRECTOR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Server Serdaroglu, Prof.Dr
role: STUDY_DIRECTOR
affiliation: Uludag University Medical Faculty
name: Emel Bulbul Baskan, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University Medical Faculty
name: Erkan Alpsoy, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Ferda Artuz, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University Medical Faculty
name: Guliz Ikizoglu, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Istanbul Medical Faculty
name: Guzin Ozarmagan, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Medical Faculty
name: Ilgen Ertam, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Erciyes University Medical Faculty
name: Murat Borlu, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Dıskapi Training and Research Hospital
name: Muzeyyen Sanlı Gonul, Ass.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University Medical Faculty
name: Nilgun Senturk, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Savas Yaylı, Ass.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziantep University Medical Faculty
name: Serhat Inaloz, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bozyaka Training and Research Hospital
name: Sinan Dogan, Spec.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara university Medical Faculty
name: Tulin Ergun, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
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