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Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

NCT ID: NCT01537432

Last Updated: 2016-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

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Detailed Description

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Conditions

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Psoriasis, Plaque-type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo comparator

secukinumab

secukinumab

Group Type EXPERIMENTAL

secukinumab

Intervention Type DRUG

secukinumab

Interventions

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secukinumab

secukinumab

Intervention Type DRUG

placebo

placebo comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic plaque-type psoriasis diagnosed for at least 6 months
* Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
* Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Exclusion Criteria

* Forms of psoriasis other than chronic plaque-type
* Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
* History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Pasadena, California, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

East Windsor, New Jersey, United States

Site Status

Novartis Investigative Site

Verona, New Jersey, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Rochester, New York, United States

Site Status

Novartis Investigative Site

High Point, North Carolina, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CAIN457A2223

Identifier Type: -

Identifier Source: org_study_id

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