E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe chronic plaque-type psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Psoriasis Area and Severity Index (PASI) 75 response rate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12-18-24-30-36-42-48-52 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 77 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Germany |
Russian Federation |
South Africa |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The End of Trial is the LPLV |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |