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

Primary Purpose

Chronic Stable Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GP2015 Etanercept
Enbrel
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 3
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 3
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 3
  • Sandoz Investigational Site 4
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site 3
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site 2
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site 1
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site
  • Sandoz Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GP2015 Etanercept

Enbrel ® Etanercept

Arm Description

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

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

Outcomes

Primary Outcome Measures

PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
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.

Secondary Outcome Measures

Percent Change From Baseline in PASI Score up to Week 12
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.
PASI 50, 75 and 90 Response Rates
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 .
Injection Site Reactions
Percentage of patients with injection site reactions up to Week 52
Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.

Full Information

First Posted
June 24, 2013
Last Updated
February 6, 2017
Sponsor
Sandoz
Collaborators
Hexal AG
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1. Study Identification

Unique Protocol Identification Number
NCT01891864
Brief Title
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Acronym
EGALITY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Hexal AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
531 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP2015 Etanercept
Arm Type
Experimental
Arm Description
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
Arm Title
Enbrel ® Etanercept
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GP2015 Etanercept
Other Intervention Name(s)
GP2015, Etanercept
Intervention Description
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
Intervention Name(s)
Enbrel
Other Intervention Name(s)
Etanercept
Intervention Description
Enbrel is used as reference product to GP2015.
Primary Outcome Measure Information:
Title
PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in PASI Score up to Week 12
Description
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.
Time Frame
12 weeks
Title
PASI 50, 75 and 90 Response Rates
Description
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 .
Time Frame
Week12
Title
Injection Site Reactions
Description
Percentage of patients with injection site reactions up to Week 52
Time Frame
Week52
Title
Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Description
Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sascha Gerdes, MD
Organizational Affiliation
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandoz Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
Sandoz Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Sandoz Investigational Site 1
City
Sofia
Country
Bulgaria
Facility Name
Sandoz Investigational Site 2
City
Sofia
Country
Bulgaria
Facility Name
Sandoz Investigational Site 3
City
Sofia
Country
Bulgaria
Facility Name
Sandoz Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
Sandoz Investigational Site
City
Prague
Country
Czech Republic
Facility Name
Sandoz Investigational Site
City
Usti nad Labem
Country
Czech Republic
Facility Name
Sandoz Investigational Site 1
City
Tallinn
Country
Estonia
Facility Name
Sandoz Investigational Site 2
City
Tallinn
Country
Estonia
Facility Name
Sandoz Investigational Site 3
City
Tallinn
Country
Estonia
Facility Name
Sandoz Investigational Site 1
City
Tartu
Country
Estonia
Facility Name
Sandoz Investigational Site 2
City
Tartu
Country
Estonia
Facility Name
Sandoz Investigational Site 1
City
Berlin
Country
Germany
Facility Name
Sandoz Investigational Site 2
City
Berlin
Country
Germany
Facility Name
Sandoz Investigational Site 1
City
Dresden
Country
Germany
Facility Name
Sandoz Investigational Site 2
City
Dresden
Country
Germany
Facility Name
Sandoz Investigational Site
City
Kiel
Country
Germany
Facility Name
Sandoz Investigational Site
City
Luebeck
Country
Germany
Facility Name
Sandoz Investigational Site
City
Munich
Country
Germany
Facility Name
Sandoz Investigational Site
City
Budapest
Country
Hungary
Facility Name
Sandoz Investigational Site
City
Debrecen
Country
Hungary
Facility Name
Sandoz Investigational Site
City
Gyula
Country
Hungary
Facility Name
Sandoz Investigational Site
City
Szolnok
Country
Hungary
Facility Name
Sandoz Investigational Site
City
Gdansk
Country
Poland
Facility Name
Sandoz Investigational Site
City
Gdynia
Country
Poland
Facility Name
Sandoz Investigational Site
City
Katowice
Country
Poland
Facility Name
Sandoz Investigational Site 1
City
Krakow
Country
Poland
Facility Name
Sandoz Investigational Site 2
City
Krakow
Country
Poland
Facility Name
Sandoz Investigational Site 1
City
Lodz
Country
Poland
Facility Name
Sandoz Investigational Site 2
City
Lodz
Country
Poland
Facility Name
Sandoz Investigational Site 3
City
Lodz
Country
Poland
Facility Name
Sandoz Investigational Site 4
City
Lodz
Country
Poland
Facility Name
Sandoz Investigational Site
City
Poznan
Country
Poland
Facility Name
Sandoz Investigational Site
City
Rzeszow
Country
Poland
Facility Name
Sandoz Investigational Site
City
Warszawa
Country
Poland
Facility Name
Sandoz Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Sandoz Investigational Site
City
Zgierz
Country
Poland
Facility Name
Sandoz Investigational Site
City
Brasov
Country
Romania
Facility Name
Sandoz Investigational Site 1
City
Bucharest
Country
Romania
Facility Name
Sandoz Investigational Site 2
City
Bucharest
Country
Romania
Facility Name
Sandoz Investigational Site 3
City
Bucharest
Country
Romania
Facility Name
Sandoz Investigational Site
City
Cluj-Napoca
Country
Romania
Facility Name
Sandoz Investigational Site 1
City
Iasi
Country
Romania
Facility Name
Sandoz Investigational Site 2
City
Iasi
Country
Romania
Facility Name
Sandoz Investigational Site
City
Targu Mures
Country
Romania
Facility Name
Sandoz Investigational Site
City
Timisoara
Country
Romania
Facility Name
Sandoz Investigational Site
City
Smolensk
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Sandoz Investigational Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Bojnice
Country
Slovakia
Facility Name
Sandoz Investigational Site 1
City
Bratislava
Country
Slovakia
Facility Name
Sandoz Investigational Site 2
City
Bratislava
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Kosice-Saka
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Kosice
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Nitra
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Svidnik
Country
Slovakia
Facility Name
Sandoz Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
Sandoz Investigational Site
City
Krugersdorp
Country
South Africa
Facility Name
Sandoz Investigational Site 1
City
Pretoria
Country
South Africa
Facility Name
Sandoz Investigational Site
City
Worcester
Country
South Africa
Facility Name
Sandoz Investigational Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Kyiv
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Rivne
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
Sandoz investigational Site
City
Zaporizhzhia
Country
Ukraine
Facility Name
Sandoz Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
Sandoz Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
Sandoz Investigational Site
City
London
Country
United Kingdom
Facility Name
Sandoz Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
Sandoz Investigational Site
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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