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

NCT ID: NCT02795416

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"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

Group Type EXPERIMENTAL

"Secukinumab" "Cosentyx TM"

Intervention Type DRUG

"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

Interventions

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"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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nilgun Atakan, Prof.Dr

Role: STUDY_DIRECTOR

Hacettepe University Medical Faculty

Server Serdaroglu, Prof.Dr

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Medical Faculty

Emel Bulbul Baskan, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Uludag University Medical Faculty

Erkan Alpsoy, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Medical Faculty

Ferda Artuz, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Guliz Ikizoglu, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Mersin University Medical Faculty

Guzin Ozarmagan, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Istanbul Medical Faculty

Ilgen Ertam, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Ege University Medical Faculty

Murat Borlu, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Erciyes University Medical Faculty

Muzeyyen Sanlı Gonul, Ass.Prof

Role: PRINCIPAL_INVESTIGATOR

Dıskapi Training and Research Hospital

Nilgun Senturk, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University Medical Faculty

Savas Yaylı, Ass.Prof

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Serhat Inaloz, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Gaziantep University Medical Faculty

Sinan Dogan, Spec.Dr

Role: PRINCIPAL_INVESTIGATOR

Bozyaka Training and Research Hospital

Tulin Ergun, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Marmara university Medical Faculty

Other Identifiers

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CAIN457ATR01

Identifier Type: -

Identifier Source: org_study_id

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