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Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel

NCT01891864 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2017-03-27

Study results available
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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.

Conditions

  • Chronic Stable Plaque Psoriasis

Interventions

DRUG

GP2015 Etanercept

Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.

DRUG

Enbrel

Enbrel is used as reference product to GP2015.

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Sascha Gerdes, MD · Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2015-03-31

Countries

  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01891864 on ClinicalTrials.gov