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

• 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: Sandoz
• Collaborator: Hexal AG
• Information provided by (Responsible Party): Sandoz

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.

Condition or disease	Intervention/treatment	Phase
Chronic Stable Plaque Psoriasis	Drug: GP2015 Etanercept; Drug: Enbrel	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 531 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: June 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: March 2015

Arms and Interventions

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: 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	Drug: Enbrel; Enbrel is used as reference product to GP2015.; Other Name: Etanercept

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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 .
3. Injection Site Reactions [ Time Frame: Week52 ]
   Percentage of patients with injection site reactions up to Week 52
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

  Show 74 Study Locations

Sponsors and Collaborators

Sandoz

Hexal AG

Investigators

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

More Information

• Responsible Party: Sandoz
• ClinicalTrials.gov Identifier: NCT01891864 History of Changes
• Other Study ID Numbers: GP15-302
• First Posted: July 3, 2013
• Results First Posted: March 27, 2017
• Last Update Posted: March 27, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors