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Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.

NCT ID: NCT02474082

Last Updated: 2017-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-06-30

Brief Summary

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This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Secukinumab

Patients in treatment arm A will receive a dose of 300 mg secukinumab administered as 2 subcutaneous injections of 150 mg in a SensoReady pen (i.e. 2 x 150 mg) at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20.

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection

Fumaric acid (initial and maintenance therapy)

Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dosetitrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.

Group Type ACTIVE_COMPARATOR

Fumaric acid

Intervention Type DRUG

Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)

Interventions

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Secukinumab

Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection

Intervention Type BIOLOGICAL

Fumaric acid

Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)

Intervention Type DRUG

Other Intervention Names

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AIN457 Fumarate, Fumaric acid, Fumaric acid esters

Eligibility Criteria

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Inclusion Criteria

* Men or women must be at least 18 years of age at the time of screening
* Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
* PASI score of \>10
* Affected body surface area (BSA) \> 10%
* DLQI \>10
* Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.

Exclusion Criteria

* Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline
* Ongoing use of other prohibited psoriasis and non-psoriasis treatment.
* Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations
* Patients with severe liver diseases
* Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers
* Patients with severe kidney diseases or serum creatinine above 1 x ULN
* Patients with known hematological disease or lab abnormalities
* Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of 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

Locations

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Novartis Investigative Site

Bad Bentheim, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Bielefeld, , Germany

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Novartis Investigative Site

Bochum, , Germany

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Novartis Investigative Site

Bochum, , Germany

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Novartis Investigative Site

Bonn, , Germany

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Novartis Investigative Site

Darmstadt, , Germany

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Novartis Investigative Site

Erlangen, , Germany

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Novartis Investigative Site

Essen, , Germany

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Novartis Investigative Site

Frankfurt, , Germany

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Novartis Investigative Site

Gera, , Germany

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Novartis Investigative Site

Halle, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hanover, , Germany

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Novartis Investigative Site

Heidelberg, , Germany

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Novartis Investigative Site

Kiel, , Germany

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Novartis Investigative Site

Ludwigshafen, , Germany

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Novartis Investigative Site

Lübeck, , Germany

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Novartis Investigative Site

Mannheim, , Germany

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Novartis Investigative Site

München, , Germany

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Novartis Investigative Site

Münster, , Germany

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Novartis Investigative Site

Osnabrück, , Germany

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Novartis Investigative Site

Quedlinburg, , Germany

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Novartis Investigative Site

Schwerin, , Germany

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Novartis Investigative Site

Selters, , Germany

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Novartis Investigative Site

Stade, , Germany

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Countries

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Germany

Other Identifiers

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CAIN457ADE06

Identifier Type: -

Identifier Source: org_study_id