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Trial record 2 of 2 for:    GP2015

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

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ClinicalTrials.gov Identifier: NCT01891864
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE July 3, 2013
Results First Submitted Date  ICMJE September 26, 2016
Results First Posted Date  ICMJE March 27, 2017
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
The primary efficacy variable is the PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1). [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • 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.
  • 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 .
  • Injection Site Reactions [ Time Frame: Week52 ]
    Percentage of patients with injection site reactions up to Week 52
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
  • PASI 50, 75 and 90 Response Rates [ Time Frame: Week12 ]
  • Time based response on PASI score [ Time Frame: Week12 ]
  • Clinical Safety and tolerability: assessment of vital signs, clinical laboratory variables, ECGs and Adverse Events monitoring [ Time Frame: Week 12 ]
  • Injection Site Reactions [ Time Frame: Week12 ]
  • Immunogenicity: Measurement of rate of ADA formations against GP2015 and Enbrel [ Time Frame: Week12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Stable Plaque Psoriasis
Intervention  ICMJE
  • 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:
    • GP2015
    • Etanercept
  • Drug: Enbrel
    Enbrel is used as reference product to GP2015.
    Other Name: Etanercept
Study Arms  ICMJE
  • 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
    Intervention: Drug: GP2015 Etanercept
  • 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
    Intervention: Drug: Enbrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2015)
531
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2013)
372
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czech Republic,   Estonia,   Germany,   Hungary,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01891864
Other Study ID Numbers  ICMJE GP15-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sandoz
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Hexal AG
Investigators  ICMJE
Principal Investigator: Sascha Gerdes, MD Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany
PRS Account Sandoz
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP