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Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

NCT ID: NCT02362789

Last Updated: 2018-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-04

Study Completion Date

2016-07-15

Brief Summary

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The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

Detailed Description

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All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Secukinumab

300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)

Placebo

Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Interventions

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Secukinumab

150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)

Intervention Type BIOLOGICAL

Placebo

Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score \> 10 at baseline.
* Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline.

Exclusion Criteria

* Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes).
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start.
* Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study.
* Pregnancy, breast feeding or inadequate contraception (if necessary)
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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Study Lead

Role: PRINCIPAL_INVESTIGATOR

Muenster

Locations

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Novartis Investigative Site

Bad Bentheim, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bielefeld, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Dippoldiswalde-Schmiedeberg, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Gelsenkirchen, , Germany

Site Status

Novartis Investigative Site

Gera, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Mannheim, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Osnabrück, , Germany

Site Status

Novartis Investigative Site

Selters, , Germany

Site Status

Novartis Investigative Site

Stuttgart, , Germany

Site Status

Novartis Investigative Site

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CAIN457ADE03

Identifier Type: -

Identifier Source: org_study_id