PsoriasisPhase 3NCT02795416

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

A Phase 3 study testing "Secukinumab" "Cosentyx TM" in people with Psoriasis, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: "Secukinumab" "Cosentyx TM"
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2016to Mar 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

About this study

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

Read the 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)

Conditions: Psoriasis
Being tested: "Secukinumab" "Cosentyx TM"
Keywords: Moderate to severe plaque psoriasis, PASI, secukinumab, monoclonal antibody, Turkish population
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"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

Study groups in NCT02795416
Study group	Role	What they receive
"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 Receives: Drug: "Secukinumab" "Cosentyx TM"

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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)
Measured: 4 week
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
Measured: 4 and 16 week
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.
Measured: 16 week
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.
Measured: 16 week
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.
Measured: 16 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Mar 2017

First posted10 Jun 2016 (estimated)
Study startJun 2016
Primary completionMar 2017 (estimated)
Study completionMar 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02795416
Sponsor's protocol ID: CAIN457ATR01
Status last verified: Apr 2017
First submitted: 16 May 2016
Last updated: 20 Apr 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02795416
Acronym / sponsor ID: CAIN457ATR01
Conditions: Psoriasis
Keywords: Moderate to severe plaque psoriasis, PASI, secukinumab, monoclonal antibody, Turkish population
Phase: Phase 3
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Mar 2017 (estimated)
Study completion: Mar 2017 (estimated)
First posted: 10 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
"Secukinumab" "Cosentyx TM"	Experimental	Drug: "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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"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	Drug	"Secukinumab" "Cosentyx TM"

Primary outcome

Percentage of PASI 90 responder patients at Week 16 as compared to baseline
Time frame: 16 week
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.

5 secondary outcomes

Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4
Time frame: 4 week
The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16
Time frame: 4 and 16 week
Work productivity (measured with WPAI-PSO) at Week 16
Time frame: 16 week
Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16
Time frame: 16 week
Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
Time frame: 16 week

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nilgun Atakan, Prof.Dr study director

Hacettepe University Medical Faculty

Server Serdaroglu, Prof.Dr study director

Istanbul University Cerrahpasa Medical Faculty

Emel Bulbul Baskan, Prof.Dr principal investigator

Uludag University Medical Faculty

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing "Secukinumab" "Cosentyx TM" in people with Psoriasis, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of PASI 90 responder patients at Week 16 as compared to baseline (time frame: 16 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02795416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.