Trial Description. Organizational Data. Secondary IDs

Transcription

1 Trial Description Title 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 Trial Acronym EGALITY URL of the trial [---]* Brief Summary in Lay Language [---]* Brief Summary in Scientific Language [---]* Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: 2013/07/04 Investigator Sponsored/Initiated Trial (IST/IIT): no Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: A 125/13, Ethikkommission der Christian-Albrechts-Universität zu Kiel Secondary IDs EudraCT-No. (for studies acc. to Drug Law): Primary Registry-ID: NCT (Clinicaltrials.gov) Page 1 of 6

2 Health condition or Problem studied Free text: Chronic Plaque type psoriasis Interventions/Observational Groups Arm 1: GP2015 (Etanercept) Solution for s.c. injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50mg once weekly thereafter. The total duration of treatment can last up to 52 weeks. Arm 2: Enbrel (Etanercept) Solution for s.c. injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50mg once weekly thereafter. The total duration of treatment can last up to 52 weeks. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: patient/subject, investigator/therapist, assessor, data analyst Control: Active control (effective treament of control group) Purpose: Treatment Assignment: Parallel Phase: III Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome 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 * PASI 50, 75 and 90 response rates * Time based response on PASI score * Clinical Safety and tolerability: assessment of vital signs, clinical laboratory variables, ECGs and Adverse Events monitoring * Injection Site Reactions * 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. Page 2 of 6

3 Countries of recruitment BG Bulgaria DE EE Estonia CZ Czech Republic UA Ukraine UK United Kingdom RU Russian Federation HU Hungary PL Poland RO Romania ZA South Africa SK Slovakia Locations of Recruitment University Medical Center Lübeck University Medical Center Kiel Doctor's Practice Dresden Doctor's Practice Hamburg University Medical Center Köln Doctor's Practice Witten University Medical Center Mainz University Medical Center Münster University Medical Center Dresden Doctor's Practice München Medical Center Berlin Doctor's Practice Berlin Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/06/24 Target Sample Size: 546 Page 3 of 6

4 Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/06/24 Target Sample Size: 546 Monocenter/Multicenter trial: Multicenter trial National/International: International Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional 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 Addresses Page 4 of 6

5 Primary Sponsor Hexal AG Industriestrasse Holzkirchen Telephone: [---]* [---]* Contact for Scientific Queries Universitätsklinikum Schleswig-Holstein, Campus Kiel Mr. Dr. Sascha Gerdes Schittenhelmstr Kiel Telephone: sgerdes at dermatology.uni-kiel.de Contact for Public Queries Universitaetsklinikum Schleswig-Holstein - Campus Kiel Mr. Dr. Sascha Gerdes Schittenhelmstrasse Kiel Telephone: sgerdes at dermatology.uni-kiel.de Sources of Monetary or Material Support Page 5 of 6

6 Commercial (pharmaceutical industry, medical engineering industry, etc.) Hexal AG Industriestrasse Holzkirchen Telephone: [---]* [---]* Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2015/03/30 Trial Publications, Results and other documents Paper [---]* * This entry means the parameter is not applicable or has not been set. Page 6 of 6