Status:
COMPLETED
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Lead Sponsor:
Sandoz
Collaborating Sponsors:
Hexal AG
Conditions:
Chronic Stable Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT01891864
Start Date
June 1 2013
End Date
March 1 2015
Last Update
March 27 2017
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
Sandoz Investigational Site
Pleven, Bulgaria
2
Sandoz Investigational Site
Plovdiv, Bulgaria
3
Sandoz Investigational Site 1
Sofia, Bulgaria
4
Sandoz Investigational Site 2
Sofia, Bulgaria