Back to results

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

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

"Secukinumab" "Cosentyx TM"

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate to severe plaque psoriasis, PASI, secukinumab, monoclonal antibody, Turkish population

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"Secukinumab" "Cosentyx TM"

Arm Description

"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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Patients, who achieved PASI 75 and PASI 90 response at week 4 will be counted by using frequencies and percentages (a subject is defined as a PASI 90 responder if the PASI score is reduced by 90% or more compared to baseline visit)

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

Investigator's Global Assessment (IGA mod 2011) score will be explained by using descriptive statistics at week 4 and week 16. Change between week 4 and week 16 comparing to baseline

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

Work productivity (WPAI-PSO) at week 16 will be evaluated by using descriptive statistics at week 16. Changes at work productivity through the visits will be inspected by using Repeated Measures ANOVA test.

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

Changes in quality of life measured with Dermatology Life Quality Index (DLQI) through visits will be evaluated by using Repeated Measures ANOVA test.

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

Health Assessment Questionnaire-Disability Index (HAQ-DI) will be evaluated at all visits by using descriptive statistics. The change between visits will be evaluated by Repeated Measures ANOVA test.

Full Information

NCT ID

NCT02795416

First Posted

May 16, 2016

Last Updated

April 19, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02795416

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Withdrawn

Study Start Date

June 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"Secukinumab" "Cosentyx TM"

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

"Secukinumab" "Cosentyx TM"

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

16 week

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 week

Title

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

Description

Investigator's Global Assessment (IGA mod 2011) score will be explained by using descriptive statistics at week 4 and week 16. Change between week 4 and week 16 comparing to baseline

Time Frame

4 and 16 week

Title

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

Description

Time Frame

16 week

Title

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

Description

Changes in quality of life measured with Dermatology Life Quality Index (DLQI) through visits will be evaluated by using Repeated Measures ANOVA test.

Time Frame

16 week

Title

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

Description

Health Assessment Questionnaire-Disability Index (HAQ-DI) will be evaluated at all visits by using descriptive statistics. The change between visits will be evaluated by Repeated Measures ANOVA test.

Time Frame

16 week

Other Pre-specified Outcome Measures:

Title

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

Description

Change in HOMA-IR level between baseline and week 16 will be evaluated

Time Frame

16 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: