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

Chronic Stable Plaque Psoriasis Clinical Trial

— EGALITY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891864
• Other study ID #: GP15-302
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2013
• Last updated: October 26, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineGermany: Paul-Ehrlich-InstitutHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: March 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Stable Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• GP2015 Etanercept

• Enbrel ® Etanercept

Locations

Country	Name	City	State
Bulgaria	Sandoz Investigational Site	Pleven
Bulgaria	Sandoz Investigational Site	Plovdiv
Bulgaria	Sandoz Investigational Site 1	Sofia
Bulgaria	Sandoz Investigational Site 2	Sofia
Bulgaria	Sandoz Investigational Site 3	Sofia
Czech Republic	Sandoz Investigational Site	Olomouc
Czech Republic	Sandoz Investigational Site	Prague
Czech Republic	Sandoz Investigational Site	Usti nad Labem
Estonia	Sandoz Investigational Site 1	Tallinn
Estonia	Sandoz Investigational Site 2	Tallinn
Estonia	Sandoz Investigational Site 3	Tallinn
Estonia	Sandoz Investigational Site 1	Tartu
Estonia	Sandoz Investigational Site 2	Tartu
Germany	Sandoz Investigational Site 1	Berlin
Germany	Sandoz Investigational Site 2	Berlin
Germany	Sandoz Investigational Site 1	Dresden
Germany	Sandoz Investigational Site 2	Dresden
Germany	Sandoz Investigational Site	Kiel
Germany	Sandoz Investigational Site	Luebeck
Germany	Sandoz Investigational Site	Munich
Hungary	Sandoz Investigational Site	Budapest
Hungary	Sandoz Investigational Site	Debrecen
Hungary	Sandoz Investigational Site	Gyula
Hungary	Sandoz Investigational Site	Szolnok
Poland	Sandoz Investigational Site	Gdansk
Poland	Sandoz Investigational Site	Gdynia
Poland	Sandoz Investigational Site	Katowice
Poland	Sandoz Investigational Site 1	Krakow
Poland	Sandoz Investigational Site 2	Krakow
Poland	Sandoz Investigational Site 1	Lodz
Poland	Sandoz Investigational Site 2	Lodz
Poland	Sandoz Investigational Site 3	Lodz
Poland	Sandoz Investigational Site 4	Lodz
Poland	Sandoz Investigational Site	Poznan
Poland	Sandoz Investigational Site	Rzeszow
Poland	Sandoz Investigational Site	Warszawa
Poland	Sandoz Investigational Site	Wroclaw
Poland	Sandoz Investigational Site	Zgierz
Romania	Sandoz Investigational Site	Brasov
Romania	Sandoz Investigational Site 1	Bucharest
Romania	Sandoz Investigational Site 2	Bucharest
Romania	Sandoz Investigational Site 3	Bucharest
Romania	Sandoz Investigational Site	Cluj-Napoca
Romania	Sandoz Investigational Site 1	Iasi
Romania	Sandoz Investigational Site 2	Iasi
Romania	Sandoz Investigational Site	Targu Mures
Romania	Sandoz Investigational Site	Timisoara
Russian Federation	Sandoz Investigational Site	Smolensk
Russian Federation	Sandoz Investigational Site	St. Petersburg
Slovakia	Sandoz Investigational Site	Banska Bystrica
Slovakia	Sandoz Investigational Site	Bojnice
Slovakia	Sandoz Investigational Site 1	Bratislava
Slovakia	Sandoz Investigational Site 2	Bratislava
Slovakia	Sandoz Investigational Site	Kosice
Slovakia	Sandoz Investigational Site	Kosice-Saka
Slovakia	Sandoz Investigational Site	Nitra
Slovakia	Sandoz Investigational Site	Svidnik
South Africa	Sandoz Investigational Site	Bloemfontein
South Africa	Sandoz Investigational Site	Krugersdorp
South Africa	Sandoz Investigational Site 1	Pretoria
South Africa	Sandoz Investigational Site	Worcester
Ukraine	Sandoz Investigational Site	Dnipropetrovsk
Ukraine	Sandoz Investigational Site	Donetsk
Ukraine	Sandoz Investigational Site	Kharkiv
Ukraine	Sandoz Investigational Site	Kyiv
Ukraine	Sandoz Investigational Site	Lugansk
Ukraine	Sandoz Investigational Site	Rivne
Ukraine	Sandoz Investigational Site	Simferopol
Ukraine	Sandoz investigational Site	Zaporizhzhia
United Kingdom	Sandoz Investigational Site	Dundee
United Kingdom	Sandoz Investigational Site	Leeds
United Kingdom	Sandoz Investigational Site	London
United Kingdom	Sandoz Investigational Site	Newcastle upon Tyne
United Kingdom	Sandoz Investigational Site	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Estonia,  Germany,  Hungary,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Week 12	No
Secondary	PASI 50, 75 and 90 response rates		Week12	No
Secondary	Time based response on PASI score		Week12	No
Secondary	Clinical Safety and tolerability: assessment of vital signs, clinical laboratory variables, ECGs and Adverse Events monitoring		Week 12	Yes
Secondary	Injection Site Reactions		Week12	Yes
Secondary	Immunogenicity: Measurement of rate of ADA formations against GP2015 and Enbrel		Week12	Yes