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

NCT01891864 | Completed Phase 3 Results DMC

• 1 other identifier: GP15-302
• Study Type: interventional
• Target: 531
• Locations: 12 countries
• Sites: 74

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.

Conditions

Chronic Stable Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (4)

• Percent Change From Baseline in PASI Score up to Week 12

  12 weeks

• PASI 50, 75 and 90 Response Rates

  Week12

• Injection Site Reactions

  Week52

• Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept

  Week 52

Study Arms (2)

GP2015 Etanercept

EXPERIMENTAL

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

Enbrel ® Etanercept

ACTIVE COMPARATOR

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

Interventions

GP2015 Etanercept DRUG

Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.

Also known as: GP2015, Etanercept

GP2015 Etanercept

Enbrel DRUG

Enbrel is used as reference product to GP2015.

Also known as: Etanercept

Enbrel ® Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (74)

Sandoz Investigational Site

Pleven, Bulgaria

Location

Sandoz Investigational Site

Plovdiv, Bulgaria

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Sandoz Investigational Site 1

Sofia, Bulgaria

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Sandoz Investigational Site 2

Sofia, Bulgaria

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Sandoz Investigational Site 3

Sofia, Bulgaria

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Sandoz Investigational Site

Olomouc, Czechia

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Sandoz Investigational Site

Prague, Czechia

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Sandoz Investigational Site

Ústí nad Labem, Czechia

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Sandoz Investigational Site 1

Tallinn, Estonia

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Sandoz Investigational Site 2

Tallinn, Estonia

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Sandoz Investigational Site 3

Tallinn, Estonia

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Sandoz Investigational Site 1

Tartu, Estonia

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Sandoz Investigational Site 2

Tartu, Estonia

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Sandoz Investigational Site 1

Berlin, Germany

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Sandoz Investigational Site 2

Berlin, Germany

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Sandoz Investigational Site 1

Dresden, Germany

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Sandoz Investigational Site 2

Dresden, Germany

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Sandoz Investigational Site

Kiel, Germany

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Sandoz Investigational Site

Lübeck, Germany

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Sandoz Investigational Site

Munich, Germany

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Sandoz Investigational Site

Budapest, Hungary

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Sandoz Investigational Site

Debrecen, Hungary

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Sandoz Investigational Site

Gyula, Hungary

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Sandoz Investigational Site

Szolnok, Hungary

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Sandoz Investigational Site

Gdansk, Poland

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Sandoz Investigational Site

Gdynia, Poland

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Sandoz Investigational Site

Katowice, Poland

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Sandoz Investigational Site 1

Krakow, Poland

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Sandoz Investigational Site 2

Krakow, Poland

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Sandoz Investigational Site 1

Lodz, Poland

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Sandoz Investigational Site 2

Lodz, Poland

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Sandoz Investigational Site 3

Lodz, Poland

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Sandoz Investigational Site 4

Lodz, Poland

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Sandoz Investigational Site

Poznan, Poland

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Sandoz Investigational Site

Rzeszów, Poland

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Sandoz Investigational Site

Warsaw, Poland

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Sandoz Investigational Site

Wroclaw, Poland

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Sandoz Investigational Site

Zgierz, Poland

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Sandoz Investigational Site

Brasov, Romania

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Sandoz Investigational Site 1

Bucharest, Romania

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Sandoz Investigational Site 2

Bucharest, Romania

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Sandoz Investigational Site 3

Bucharest, Romania

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Sandoz Investigational Site

Cluj-Napoca, Romania

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Sandoz Investigational Site 1

Iași, Romania

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Sandoz Investigational Site 2

Iași, Romania

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Sandoz Investigational Site

Târgu Mureş, Romania

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Sandoz Investigational Site

Timișoara, Romania

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Sandoz Investigational Site

Saint Petersburg, Russia

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Sandoz Investigational Site

Smolensk, Russia

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Sandoz Investigational Site

Banská Bystrica, Slovakia

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Sandoz Investigational Site

Bojnice, Slovakia

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Sandoz Investigational Site 1

Bratislava, Slovakia

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Sandoz Investigational Site 2

Bratislava, Slovakia

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Sandoz Investigational Site

Kosice-Saka, Slovakia

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Sandoz Investigational Site

Košice, Slovakia

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Sandoz Investigational Site

Nitra, Slovakia

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Sandoz Investigational Site

Svidník, Slovakia

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Sandoz Investigational Site

Bloemfontein, South Africa

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Sandoz Investigational Site

Krugersdorp, South Africa

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Sandoz Investigational Site 1

Pretoria, South Africa

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Sandoz Investigational Site

Worcester, South Africa

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Sandoz Investigational Site

Dnipropetrovsk, Ukraine

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Sandoz Investigational Site

Donetsk, Ukraine

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Sandoz Investigational Site

Kharkiv, Ukraine

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Sandoz Investigational Site

Kyiv, Ukraine

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Sandoz Investigational Site

Luhansk, Ukraine

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Sandoz Investigational Site

Rivne, Ukraine

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Sandoz Investigational Site

Simferopol, Ukraine

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Sandoz investigational Site

Zaporizhzhia, Ukraine

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Sandoz Investigational Site

Dundee, United Kingdom

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Sandoz Investigational Site

Leeds, United Kingdom

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Sandoz Investigational Site

London, United Kingdom

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Sandoz Investigational Site

Newcastle upon Tyne, United Kingdom

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Sandoz Investigational Site

Salford, United Kingdom

Location

Related Publications (1)

• Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25.

  PMID: 40279006 DERIVED

MeSH Terms

Interventions

GP2015; Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

None reported

Results Point of Contact

• Title: Dr Guido Wuerth - Global Program Medical Director
• Organization: Sandoz

guido.wuerth@sandoz.com

+4980244762925

Study Officials

• Sascha Gerdes, MD

  Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 3, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2); SL (8); RO (9); BU (5); HU (4); UA (8); PL (14); ES (5); ZA (4); DE (7); CZ (3); GB (5)