Phase 3
Completed N=531
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Chronic Stable Plaque Psoriasis
Source: ClinicalTrials.gov NCT01891864 ↗
Enrolled (actual)
531
Serious AEs
4.9%
Results posted
Mar 2017
Primary outcomePrimary: PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept — 73.4; 75.7 % of patients achieving PASI75 response
◆ Published Evidence
Not yet cited
0citations
Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA).
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.
Linked Publications
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Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept |
73.4; 75.7 | — |
| SECONDARY Percent Change From Baseline in PASI Score up to Week 12 |
-56.11; -55.48 | — |
| SECONDARY PASI 50, 75 and 90 Response Rates |
99.2; 97.9; 73.4; 75.7; 39.2; 34.1 | — |
| SECONDARY Injection Site Reactions |
8.5; 16.7; 9.0; 15.8 | — |
| SECONDARY Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept |
0; 1.1; 0; 3.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01891864) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.