Clinical trial NCT01891864: Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Stable Plaque Psoriasis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2013-07-03
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in PASI Score up to Week 12
timeFrame: 12 weeks
measure: PASI 50, 75 and 90 Response Rates
timeFrame: Week12
measure: Injection Site Reactions
timeFrame: Week52
measure: Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
timeFrame: Week 52
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Sandoz Investigational Site
city: Plovdiv
country: Bulgaria
facility: Sandoz Investigational Site
city: Sofia
country: Bulgaria
facility: Sandoz Investigational Site 1
city: Sofia
country: Bulgaria
facility: Sandoz Investigational Site 2
city: Sofia
country: Bulgaria
facility: Sandoz Investigational Site 3
city: Olomouc
country: Czech Republic
facility: Sandoz Investigational Site
city: Prague
country: Czech Republic
facility: Sandoz Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Sandoz Investigational Site
city: Tallinn
country: Estonia
facility: Sandoz Investigational Site 1
city: Tallinn
country: Estonia
facility: Sandoz Investigational Site 2
city: Tallinn
country: Estonia
facility: Sandoz Investigational Site 3
city: Tartu
country: Estonia
facility: Sandoz Investigational Site 1
city: Tartu
country: Estonia
facility: Sandoz Investigational Site 2
city: Berlin
country: Germany
facility: Sandoz Investigational Site 1
city: Berlin
country: Germany
facility: Sandoz Investigational Site 2
city: Dresden
country: Germany
facility: Sandoz Investigational Site 1
city: Dresden
country: Germany
facility: Sandoz Investigational Site 2
city: Kiel
country: Germany
facility: Sandoz Investigational Site
city: Luebeck
country: Germany
facility: Sandoz Investigational Site
city: Munich
country: Germany
facility: Sandoz Investigational Site
city: Budapest
country: Hungary
facility: Sandoz Investigational Site
city: Debrecen
country: Hungary
facility: Sandoz Investigational Site
city: Gyula
country: Hungary
facility: Sandoz Investigational Site
city: Szolnok
country: Hungary
facility: Sandoz Investigational Site
city: Gdansk
country: Poland
facility: Sandoz Investigational Site
city: Gdynia
country: Poland
facility: Sandoz Investigational Site
city: Katowice
country: Poland
facility: Sandoz Investigational Site
city: Krakow
country: Poland
facility: Sandoz Investigational Site 1
city: Krakow
country: Poland
facility: Sandoz Investigational Site 2
city: Lodz
country: Poland
facility: Sandoz Investigational Site 1
city: Lodz
country: Poland
facility: Sandoz Investigational Site 2
city: Lodz
country: Poland
facility: Sandoz Investigational Site 3
city: Lodz
country: Poland
facility: Sandoz Investigational Site 4
city: Poznan
country: Poland
facility: Sandoz Investigational Site
city: Rzeszow
country: Poland
facility: Sandoz Investigational Site
city: Warszawa
country: Poland
facility: Sandoz Investigational Site
city: Wroclaw
country: Poland
facility: Sandoz Investigational Site
city: Zgierz
country: Poland
facility: Sandoz Investigational Site
city: Brasov
country: Romania
facility: Sandoz Investigational Site
city: Bucharest
country: Romania
facility: Sandoz Investigational Site 1
city: Bucharest
country: Romania
facility: Sandoz Investigational Site 2
city: Bucharest
country: Romania
facility: Sandoz Investigational Site 3
city: Cluj-Napoca
country: Romania
facility: Sandoz Investigational Site
city: Iasi
country: Romania
facility: Sandoz Investigational Site 1
city: Iasi
country: Romania
facility: Sandoz Investigational Site 2
city: Targu Mures
country: Romania
facility: Sandoz Investigational Site
city: Timisoara
country: Romania
facility: Sandoz Investigational Site
city: Smolensk
country: Russian Federation
facility: Sandoz Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Sandoz Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Sandoz Investigational Site
city: Bojnice
country: Slovakia
facility: Sandoz Investigational Site
city: Bratislava
country: Slovakia
facility: Sandoz Investigational Site 1
city: Bratislava
country: Slovakia
facility: Sandoz Investigational Site 2
city: Kosice-Saka
country: Slovakia
facility: Sandoz Investigational Site
city: Kosice
country: Slovakia
facility: Sandoz Investigational Site
city: Nitra
country: Slovakia
facility: Sandoz Investigational Site
city: Svidnik
country: Slovakia
facility: Sandoz Investigational Site
city: Bloemfontein
country: South Africa
facility: Sandoz Investigational Site
city: Krugersdorp
country: South Africa
facility: Sandoz Investigational Site
city: Pretoria
country: South Africa
facility: Sandoz Investigational Site 1
city: Worcester
country: South Africa
facility: Sandoz Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Sandoz Investigational Site
city: Donetsk
country: Ukraine
facility: Sandoz Investigational Site
city: Kharkiv
country: Ukraine
facility: Sandoz Investigational Site
city: Kyiv
country: Ukraine
facility: Sandoz Investigational Site
city: Lugansk
country: Ukraine
facility: Sandoz Investigational Site
city: Rivne
country: Ukraine
facility: Sandoz Investigational Site
city: Simferopol
country: Ukraine
facility: Sandoz Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Sandoz investigational Site
city: Dundee
country: United Kingdom
facility: Sandoz Investigational Site
city: Leeds
country: United Kingdom
facility: Sandoz Investigational Site
city: London
country: United Kingdom
facility: Sandoz Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Sandoz Investigational Site
city: Salford
country: United Kingdom
facility: Sandoz Investigational Site
Study officials:
affiliation: Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany
name: Sascha Gerdes, MD
role: PRINCIPAL_INVESTIGATOR
References: