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4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

NCT ID: NCT01640951

Last Updated: 2018-05-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-16

Study Completion Date

2017-05-04

Brief Summary

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CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

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Detailed Description

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Conditions

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Moderate to Severe Chronic Plaque-Type Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457 150 mg - Fixed Interval (FI)

1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks

Group Type EXPERIMENTAL

AIN457 150 mg

Intervention Type DRUG

(1 injection per dose) and placebo to Secukinumab 150 mg

Placebo

Intervention Type DRUG

AIN457 150 mg - Start of relapse (SoR)

Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks

Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Group Type EXPERIMENTAL

AIN457 150 mg

Intervention Type DRUG

(1 injection per dose) and placebo to Secukinumab 150 mg

Placebo

Intervention Type DRUG

AIN457 300 mg - Fixed Interval (FI)

2 s.c. Secukinumab 150 mg PFS injections every 4 weeks

Group Type EXPERIMENTAL

AIN457 300 mg

Intervention Type DRUG

Secukinumab 150 mg (2 injections per dose)

AIN457 300 mg - Start of Relapse (SoR)

Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks

Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Group Type EXPERIMENTAL

AIN457 300 mg

Intervention Type DRUG

Secukinumab 150 mg (2 injections per dose)

Placebo

Intervention Type DRUG

AIN457 300 mg - Open Label (OL)

Open Label - Secukinumab 300mg every 4 weeks

Group Type EXPERIMENTAL

AIN457 300 mg

Intervention Type DRUG

Secukinumab 150 mg (2 injections per dose)

Interventions

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AIN457 150 mg

(1 injection per dose) and placebo to Secukinumab 150 mg

Intervention Type DRUG

AIN457 300 mg

Secukinumab 150 mg (2 injections per dose)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Secukinumab 150 mg Secukinumab 300 mg

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.
2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
3. Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator

Exclusion Criteria

1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
3. Subjects expected to be exposed to an undue safety risk if participating in the trial
4. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
5. Plans for administration of live vaccines during the study period
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL).
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

Fresno, California, United States

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Pasadena, California, United States

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San Francisco, California, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Champaign, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Boston, Massachusetts, United States

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Fridley, Minnesota, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Verona, New Jersey, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Anderson, South Carolina, United States

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Greer, South Carolina, United States

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Goodlettsville, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Wels, , Austria

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Barrie, Ontario, Canada

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Oakville, Ontario, Canada

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Waterloo, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Brno - Bohunice, Czech Republic, Czechia

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Hradec Králové, CZE, Czechia

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Prague, CZE, Czechia

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České Budějovice, , Czechia

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Nový Jičín, , Czechia

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Prague, , Czechia

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Antony, , France

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Nice, , France

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Pierre-Bénite, , France

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Rouen, , France

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Toulouse, , France

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Cologne, North Rhine-Westphalia, Germany

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Bad Wildbad, , Germany

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Bochum, , Germany

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Buchholz I. D. Nordheide, , Germany

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Dippoldiswalde-Schmiedeberg, , Germany

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Duisburg, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Kiel, , Germany

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Lübeck, , Germany

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Mahlow, , Germany

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Mainz, , Germany

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Münster, , Germany

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Wuppertal, , Germany

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Roma, RM, Italy

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Roma, RM, Italy

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Siena, SI, Italy

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Verona, VR, Italy

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Nagoya, Aichi-ken, Japan

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Kisarazu, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Osaka, Osaka, Japan

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Shimotsuke, Tochigi, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Lodz, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Košice, Slovak Republic, Slovakia

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Košice, , Slovakia

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Poprad, , Slovakia

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Svidník, , Slovakia

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Žilina, , Slovakia

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Bern, , Switzerland

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Lausanne, , Switzerland

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Zurich, , Switzerland

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Leytonstone, London, United Kingdom

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Birmingham, , United Kingdom

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Blackpool, , United Kingdom

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Leicester, , United Kingdom

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Poole, , United Kingdom

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Ho Chi Minh City, VNM, Vietnam

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Hanoi, , Vietnam

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Austria Bulgaria Canada Czechia France Germany Italy Japan Poland Singapore Slovakia Switzerland United Kingdom Vietnam

References

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Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

Reference Type DERIVED
PMID: 28580579 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2012-000985-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2304E1

Identifier Type: -

Identifier Source: org_study_id

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