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Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

NCT ID: NCT01412944

Last Updated: 2015-03-18

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

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The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

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Detailed Description

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Conditions

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Plaque-type 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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AIN457 subcutaneous (s.c.)

During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Group Type EXPERIMENTAL

secukinumab 150mg

Intervention Type DRUG

secukinumab 150mg (2 injections per dose)

AIN457 I.V.

During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Group Type EXPERIMENTAL

secukinumab 10mg/kg i.v. regimen

Intervention Type DRUG

secukinumab 10mg/kg i.v. regimen

Interventions

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secukinumab 150mg

secukinumab 150mg (2 injections per dose)

Intervention Type DRUG

secukinumab 10mg/kg i.v. regimen

secukinumab 10mg/kg i.v. regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent must be obtained before any assessment is performed,
* Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
* Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but \< 75 response.

Exclusion Criteria

* Pregnant women or lactating women
* Forms of psoriasis other than chronic plaque -type
* Ongoing use of prohibited psoriasis treatments
* Ongoing use of other non-psoriasis prohibited treatments
* Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
* Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
* UV therapy or excessive exposure to sunlight
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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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Jacksonville, Florida, United States

Site Status

Novartis Investigative Site

West Palm Beach, Florida, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Greensboro, North Carolina, United States

Site Status

Novartis Investigative Site

Greer, South Carolina, United States

Site Status

Novartis Investigative Site

Wels, Austria, Austria

Site Status

Novartis Investigative Site

Graz, , Austria

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Barrie, Ontario, Canada

Site Status

Novartis Investigative Site

Waterloo, Ontario, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Toulouse, France, France

Site Status

Novartis Investigative Site

Rouen, , France

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Lübeck, , Germany

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

Mangalore, Karnataka, India

Site Status

Novartis Investigative Site

Nagpur, Maharashtra, India

Site Status

Novartis Investigative Site

Nashik, Maharashtra, India

Site Status

Novartis Investigative Site

Kisarazu, Chiba, Japan

Site Status

Novartis Investigative Site

Hachiōji, Tokyo, Japan

Site Status

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Košice, Slovak Republic, Slovakia

Site Status

Countries

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United States Austria Canada France Germany India Japan Slovakia

Other Identifiers

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2011-002510-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2307

Identifier Type: -

Identifier Source: org_study_id

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