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

February 6, 2017 updated by: Sandoz

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Etanercept (GP2015) and Enbrel® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

531

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Sandoz Investigational Site
      • Plovdiv, Bulgaria
        • Sandoz Investigational Site
      • Sofia, Bulgaria
        • Sandoz Investigational Site 1
      • Sofia, Bulgaria
        • Sandoz Investigational Site 2
      • Sofia, Bulgaria
        • Sandoz Investigational Site 3
  • Czech Republic
      • Olomouc, Czech Republic
        • Sandoz Investigational Site
      • Prague, Czech Republic
        • Sandoz Investigational Site
      • Usti nad Labem, Czech Republic
        • Sandoz Investigational Site
  • Estonia
      • Tallinn, Estonia
        • Sandoz Investigational Site 1
      • Tallinn, Estonia
        • Sandoz Investigational Site 2
      • Tallinn, Estonia
        • Sandoz Investigational Site 3
      • Tartu, Estonia
        • Sandoz Investigational Site 1
      • Tartu, Estonia
        • Sandoz Investigational Site 2
  • Germany
      • Berlin, Germany
        • Sandoz Investigational Site 1
      • Berlin, Germany
        • Sandoz Investigational Site 2
      • Dresden, Germany
        • Sandoz Investigational Site 1
      • Dresden, Germany
        • Sandoz Investigational Site 2
      • Kiel, Germany
        • Sandoz Investigational Site
      • Luebeck, Germany
        • Sandoz Investigational Site
      • Munich, Germany
        • Sandoz Investigational Site
  • Hungary
      • Budapest, Hungary
        • Sandoz Investigational Site
      • Debrecen, Hungary
        • Sandoz Investigational Site
      • Gyula, Hungary
        • Sandoz Investigational Site
      • Szolnok, Hungary
        • Sandoz Investigational Site
  • Poland
      • Gdansk, Poland
        • Sandoz Investigational Site
      • Gdynia, Poland
        • Sandoz Investigational Site
      • Katowice, Poland
        • Sandoz Investigational Site
      • Krakow, Poland
        • Sandoz Investigational Site 1
      • Krakow, Poland
        • Sandoz Investigational Site 2
      • Lodz, Poland
        • Sandoz Investigational Site 1
      • Lodz, Poland
        • Sandoz Investigational Site 2
      • Lodz, Poland
        • Sandoz Investigational Site 3
      • Lodz, Poland
        • Sandoz Investigational Site 4
      • Poznan, Poland
        • Sandoz Investigational Site
      • Rzeszow, Poland
        • Sandoz Investigational Site
      • Warszawa, Poland
        • Sandoz Investigational Site
      • Wroclaw, Poland
        • Sandoz Investigational Site
      • Zgierz, Poland
        • Sandoz Investigational Site
  • Romania
      • Brasov, Romania
        • Sandoz Investigational Site
      • Bucharest, Romania
        • Sandoz Investigational Site 1
      • Bucharest, Romania
        • Sandoz Investigational Site 2
      • Bucharest, Romania
        • Sandoz Investigational Site 3
      • Cluj-Napoca, Romania
        • Sandoz Investigational Site
      • Iasi, Romania
        • Sandoz Investigational Site 1
      • Iasi, Romania
        • Sandoz Investigational Site 2
      • Targu Mures, Romania
        • Sandoz Investigational Site
      • Timisoara, Romania
        • Sandoz Investigational Site
  • Russian Federation
      • Smolensk, Russian Federation
        • Sandoz Investigational Site
      • St. Petersburg, Russian Federation
        • Sandoz Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Sandoz Investigational Site
      • Bojnice, Slovakia
        • Sandoz Investigational Site
      • Bratislava, Slovakia
        • Sandoz Investigational Site 1
      • Bratislava, Slovakia
        • Sandoz Investigational Site 2
      • Kosice, Slovakia
        • Sandoz Investigational Site
      • Kosice-Saka, Slovakia
        • Sandoz Investigational Site
      • Nitra, Slovakia
        • Sandoz Investigational Site
      • Svidnik, Slovakia
        • Sandoz Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • Sandoz Investigational Site
      • Krugersdorp, South Africa
        • Sandoz Investigational Site
      • Pretoria, South Africa
        • Sandoz Investigational Site 1
      • Worcester, South Africa
        • Sandoz Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Sandoz Investigational Site
      • Donetsk, Ukraine
        • Sandoz Investigational Site
      • Kharkiv, Ukraine
        • Sandoz Investigational Site
      • Kyiv, Ukraine
        • Sandoz Investigational Site
      • Lugansk, Ukraine
        • Sandoz Investigational Site
      • Rivne, Ukraine
        • Sandoz Investigational Site
      • Simferopol, Ukraine
        • Sandoz Investigational Site
      • Zaporizhzhia, Ukraine
        • Sandoz Investigational Site
  • United Kingdom
      • Dundee, United Kingdom
        • Sandoz Investigational Site
      • Leeds, United Kingdom
        • Sandoz Investigational Site
      • London, United Kingdom
        • Sandoz Investigational Site
      • Newcastle upon Tyne, United Kingdom
        • Sandoz Investigational Site
      • Salford, United Kingdom
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Other In-/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: GP2015 Etanercept
Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.
Other Names:
  • Etanercept
  • GP2015
Active Comparator: 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
Drug: Enbrel
Enbrel is used as reference product to GP2015.
Other Names:
  • Etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
Time Frame: Week 12
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in PASI Score up to Week 12
Time Frame: 12 weeks
The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.
12 weeks
PASI 50, 75 and 90 Response Rates
Time Frame: Week12
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .
Week12
Injection Site Reactions
Time Frame: Week52
Percentage of patients with injection site reactions up to Week 52
Week52
Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Time Frame: Week 52
Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Hexal AG

Investigators

  • Principal Investigator: Sascha Gerdes, MD, Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP15-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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