Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) … (NCT01891864) | Clinical Trial Compass
CompletedPhase 3
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Bulgaria531 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept