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

Phase 3

Completed

• Conditions: Chronic Stable Plaque Psoriasis
• Interventions: Drug: GP2015 Etanercept; Drug: Enbrel

• Registration Number: NCT01891864
• Lead Sponsor: Sandoz

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Primary Completion: 2014-06
• Study Completion: 2015-03
• Results First Submitted: 2016-09-26
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-06
• Last Update Submitted: 2017-02-06
• Results First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 531

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP2015 Etanercept	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
Enbrel ® Etanercept	Enbrel	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in PASI Score up to Week 12	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	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	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	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.

Trial Locations

Locations (6)

Sandoz Investigational Site 2; 🇸🇰 Bratislava, Slovakia

Sandoz Investigational Site 3; 🇷🇴 Bucharest, Romania

Sandoz Investigational Site 4; 🇵🇱 Lodz, Poland

Sandoz investigational Site; 🇺🇦 Zaporizhzhia, Ukraine

Sandoz Investigational Site; 🇬🇧 Salford, United Kingdom

Sandoz Investigational Site 1; 🇿🇦 Pretoria, South Africa