E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This pilot lab-based study will assess skin biopsies from psoriatic patients treated with infliximab and aim to compare the proteomic profiles of samples obtained under the following conditions: 1- psoriatic non-lesional skin;2- psoriatic lesional skin or previous lesional skin, before and after 12 weeks of therapy with infliximab. The therapeutic changes in protein profile will help to correlate disease-modifying effects at molecular level with clinical outcomes.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
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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 compare the proteomic profiles of skin samples obtained from psoriatic patients before starting and under infliximab treatment from: 1- Psoriatic non-lesional skin 2- psoriatic lesional skin
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E.2.2 | Secondary objectives of the trial |
1-Identify disease and therapeutic biomarkers 2- Correlate the disease-modifying effects at molecualr level with clinical outcomes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Moderate to severe chronic plaque-psoriasis, assessed by PASI score > 10 2- Clinical indicaition to infliximab therapy 3- > 18 years old 4- Written infromed consent prior to any study related procedure 5- 60 days washout of prior systemic therapy 6- No primary vaccinations < 6 weeks before trial inclusion |
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E.4 | Principal exclusion criteria |
1- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis 2- History of severe allergic or anaphylactic reactions to monoclonal antibodies 3- Ongoing uncontrolled bacterial, fungal or atypical mycobacterial infection 4- Opportunistic infection 5- Seropositivity for HIV, HBV or HBC virus 6- Pregnancy or breastfeeding 7- Hematological abnormalities 8- History of active tuberculosis or treatment for TB in the previous year 9- Lupus or elevation of ANA / anti dsDNA titers 10- Any malignancy in the previous 5 years, including lymphoproliferative disorders. Patients with fully resolved basel cell or squamous cell skin cancer may be enrolled. 11- Hospital admission for cardiac disease, stroke, pulmonary disease < 1year. 12- Any medical condition that, in the judgement of the investigator, would jeopardize the patient safety. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patients reaching greater or equal PASI 75 response at week 12 will be eligible for sample collection for this research study that will compare the proteome of non-lesional and lesional skin samples before and under 12 weeks of infliximab treatment. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Proteomics (laboratory research study) |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
basic investigational study |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |