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

Phase 3

• Conditions: Chronic Plaque type psoriasis

• Registration Number: DRKS00005365
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-24
• Study Completion: 2015-03-30
• Results First Posted: 2016-10-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 531

Inclusion Criteria

•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.

Other Inclusion criteria may apply

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 exclusion criteria may apply

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
* PASI 50, 75 and 90 response rates<br>* Time based response on PASI score<br>* Clinical Safety and tolerability: assessment of vital signs, clinical laboratory variables, ECGs and Adverse Events monitoring<br>* Injection Site Reactions<br>* Immunogenicity: Measurement of rate of ADA (Anti-drug antibodies) formations against GP2015 and Enbrel. All secondary endpoints are assessed during the complete duration of the study until week 52.