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

Sandoz

Status and phase: Completed; Phase 3

Conditions: Chronic Stable Plaque Psoriasis

Treatments: Drug: GP2015 Etanercept; Drug: Enbrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01891864

GP15-302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 531 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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531 participants in 2 patient groups

GP2015 Etanercept

Experimental group

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

Treatment:

Drug: GP2015 Etanercept

Enbrel ® Etanercept

Active Comparator group

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

Treatment:

Drug: Enbrel