E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
The primary objective of the study is to compare the efficacy of CZP administered sc at the doses of CZP 400mg Q2W and CZP 200mg Q2W after a loading dose of CZP 400mg Q2W at Weeks 0, 2, and 4 to PBO in the treatment of moderate to severe chronic plaque PSO. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective
•Compare the efficacy of CZP administered sc at the doses of CZP 400mg Q2W and CZP 200mg Q2W after a loading dose of CZP 400mg at Weeks 0, 2, and 4 to ETN administered sc twice weekly at a cumulative weekly dose of 100mg in the treatment of moderate to severe chronic plaque PSO.
•Assess the optimal initial treatment dose for the treatment of moderate to severe chronic
plaque PSO
•Assess the optimal maintenance dose for the treatment of moderate to severe chronic plaque
PSO
•Assess the safety and tolerability of CZP
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Photographs sub-study: at sites selected for the sub-study, representative photographs of the changes in skin and nail appearance will be captured. Subjects will have full body (anterior and posterior views, below neck) and target nail photographs taken. Photographs will be ananomized.
The assessment is scheduled on baseline, week 12, week 16, week 48. |
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E.3 | Principal inclusion criteria |
1.Provided informed consent
2.Adult men or women ≥18 years
3.Chronic plaque psoriasis for at least 6 months
4.Baseline psoriasis activity and severity index ≥12 and body surface area ≥10% and Physician’s Global Assessments score ≥3
5.Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
6.Other protocol-defined inclusion criteria may apply
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E.4 | Principal exclusion criteria |
1.Erythrodermic, guttate, generalized pustular form of psoriasis
2.History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
3.Congestive heart failure
4.History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
5.History of other malignancy concurrent malignancy as described in the protocol
6.History of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
7.Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
8.Any other condition which, in the Investigator’s judgment, would make the subject unsuitable for participation in the study
9.Other protocol-defined exclusion criteria may apply
10.Prior etanercept use |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the PASI75 responder rate at Week 12. A subject will be classified as a PASI75 responder if the PASI score at the visit has improved at least 75% from Baseline.
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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) |
Secondary efficacy variables include PGA response of Clear or Almost
clear (with at least a 2 category improvement) at Week 12 and Week 16,
PASI 90 response at Weeks 12 and 16, PASI 75 response at Week 16,
and PASI 75 response at Week 48 for subject achieving PASI 75
response at Week 16 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From Baseline to Week 12, Week 16, Week 48 |
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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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Double blind phase is followed by placebo controlled phase, open label phase and safety follow up. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 |
Bulgaria |
Czech Republic |
France |
Germany |
Hungary |
Netherlands |
Poland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |