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Study to Demonstrate Equivale...

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel

Last Updated: 2017-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.

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Detailed Description

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The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.

Conditions

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Chronic Stable Plaque 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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GP2015 Etanercept

Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter

Group Type EXPERIMENTAL

GP2015 Etanercept

Intervention Type DRUG

Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.

Enbrel ® Etanercept

Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter

Group Type ACTIVE_COMPARATOR

Enbrel

Intervention Type DRUG

Enbrel is used as reference product to GP2015.

Interventions

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GP2015 Etanercept

Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.

Intervention Type DRUG

Enbrel

Enbrel is used as reference product to GP2015.

Intervention Type DRUG

Other Intervention Names

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GP2015 Etanercept Etanercept

Eligibility Criteria

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Inclusion Criteria

* Men or women at least 18 years of age at time of screening
* Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline
* Moderate to severe psoriasis as defined at baseline by:

* PASI score of 10 or greater and,
* Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
* Body Surface Area affected by plaque-type psoriasis of 10% or greater
* Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion Criteria

* Forms of psoriasis other than chronic plaque-type
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Previous exposure to etanercept
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers