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

NCT02795416 | Withdrawn Phase 3

• 1 other identifier: CAIN457ATR01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Moderate to severe plaque psoriasis, PASI, secukinumab, monoclonal antibody, Turkish population

Outcome Measures

Primary Outcomes (1)

• Percentage of PASI 90 responder patients at Week 16 as compared to baseline

  The primary endpoint has been chosen as percentage of PASI 90 responder patients. PASI 90 is accepted as clear or almost clear of psoriatic lesions which are the ultimate goal of treatment in plaque psoriasis.

  16 week

Secondary Outcomes (5)

• Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4

  4 week

• The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16

  4 and 16 week

• Work productivity (measured with WPAI-PSO) at Week 16

  16 week

• Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16

  16 week

• Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)

  16 week

Other Outcomes (1)

• In case of insulin resistance determined at the baseline, the change in the resistance level as measured by HOMA-IR

  16 week

Study Arms (1)

"Secukinumab" "Cosentyx TM"

EXPERIMENTAL

"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

Drug: "Secukinumab" "Cosentyx TM"

Interventions

"Secukinumab" "Cosentyx TM" 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

"Secukinumab" "Cosentyx TM"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nilgun Atakan, Prof.Dr

  Hacettepe University Medical Faculty

  STUDY DIRECTOR

• Server Serdaroglu, Prof.Dr

  Istanbul University Cerrahpasa Medical Faculty

  STUDY DIRECTOR

• Emel Bulbul Baskan, Prof.Dr

  Uludag University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Erkan Alpsoy, Prof.Dr

  Akdeniz University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Ferda Artuz, Prof.Dr

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Guliz Ikizoglu, Prof.Dr

  Mersin University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Guzin Ozarmagan, Prof.Dr

  Istanbul University Istanbul Medical Faculty

  PRINCIPAL INVESTIGATOR

• Ilgen Ertam, Prof.Dr

  Ege University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Murat Borlu, Prof.Dr

  Erciyes University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Muzeyyen Sanlı Gonul, Ass.Prof

  Dıskapi Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Nilgun Senturk, Prof.Dr

  Ondokuz Mayıs University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Savas Yaylı, Ass.Prof

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Serhat Inaloz, Prof.Dr.

  Gaziantep University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Sinan Dogan, Spec.Dr

  Bozyaka Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Tulin Ergun, Prof.Dr

  Marmara university Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: June 10, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04