moderate to severe chronic plaque-type psoriasis MedDRA version: 17.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Etanercept
Product Code: GP2015
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Current Sponsor code: GP2015
Con
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be able to understand and communicate with the investigator and comply with the requirements of the study [including administration of subcutaneous (s.c.) injections at home] and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations 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, • IGA score of 3 or greater (based on a scale of 0 - 4) and, • BSA 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g. beta-blockers, or lithium) Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV-therapy). Washout periods detailed in the protocol have to be adhered to Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before baseline Previous exposure to etanercept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1) Secondary objectives Period 1 • To compare PASI 50, PASI 75, and PASI 90 response rates of GP2015 and Enbrel® • To compare the response of patients treated with GP2015 and Enbrel® over time based on the PASI score • To compare the response rates of GP2015 and Enbrel® determined by the Investigator’s Global Assessment (IGA) of disease activity • To compare the health-related quality of life during treatment with GP2015 and Enbrel® by the Dermatology Life Quality Index (DLQI) and the EuroQol 5-Dimension Health Status Questionnaire (EQ-5DTM) 2) Secondary objectives Period 2 • To compare efficacy, safety, and immunogenicity of pooled data from patients undergoing repeated switches (Groups 1b and 2b) with those from patients constantly treated with GP2015 (Group 1a) and Enbrel® (Group 2a) • To compare efficacy, safety, and immunogenicity of data from patients constantly treated with GP2015 (Group 1a) versus those of patients constantly treated with Enbrel® (Group 2a);Primary end point(s): Psoriasis Area and Severity Index (PASI) 75 response rate;Timepoint(s) of evaluation of this end point: at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12-18-24-30 weeks;Secondary end point(s): Efficacy assessments: • Investigator’s Global Assessment (IGA); scale from 0 to 4 Safety assessments: • Physical examination and vital signs • Electrocardiogram (ECG) • Laboratory assessments: hematology, clinical chemistry, pregnancy tests • Assessment of Injection Site Reaction (ISRs) Immunogenicity assessment Anti-drug Antibody (ADA) will be analyzed prior to the first injection of IMP, at all visits during both treatment periods, and at follow-up visit four weeks after the last administration of IMP. Pharmacokinetic (PK) assessment At Baseline (Day 1) and at Weeks 2, 4, 8 and 12 trough serum concentrations of etanercept will be analyzed in a subset of approximately 50 patients (about 25 patients treated with GP2015 and 25 patients treated with Enbrel®). Other assessments • Health-related quality of life: The impact of psoriasis on various aspects of patient’s health-related quality of life will be assessed by the following validated instruments: • Dermatology Life Quality Index (DLQI) • EuroQol 5-Dimension Health Status Questionnaire: EQ-5D (TM) • Health Assessment Questionnaire-Disability Index (HAQ-DI©) - only in patients with a medical history of Psoriatic Arthritis • Photography (optional, at selected sites only) • Pharmacodynamic (PD) markers including high sensitivity C-reactive protein (hsCRP) | — |
Countries
Bulgaria, Czech Republic, Estonia, Germany, Hungary, India, Poland, Russian Federation, Slovakia, South Africa, Ukraine, United Kingdom
Contacts
Public ContactGlobal Clinical Development Manager
HEXAL AG
Outcome results
None listed