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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
531

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hexal AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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