E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subject with chronic (disease history of at least 6 months from diagnosis) moderate to severe plaque psoriasis involving the hands and/or feet (PGA – H&F ratings of 3 or 4) at screening, who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 evaluate the safety and efficacy of Raptiva ® against placebo to control chronic moderate to severe plaque-type psoriasis involving hands and/or feet scoring PGA (PGA - H&F) ≥3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and PUVA. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the evolution of psoriasis events (rebound or exacerbation), during Raptiva ® therapy or after its discontinuation for any cause. Exacerbation: continuous and slow disease worsening either during or after treatment, and occurring either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease, compared to baseline.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Subject with chronic (disease history of at least 6 months from diagnosis) moderate to severe plaque psoriasis involving the hands and/or feet (PGA – H&F ratings of 3 or 4) at screening, who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA. Subjects will be outpatients. 2) Stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period). 3) At least 18 years old. 4) For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. 5) Discontinuation of any systemic psoriasis treatment at study entry. No washout period is required for these traditional systemic psoriasis agents prior to starting study treatment. 6) Discontinuation of all biological agents at least 3 months prior to first study injection. 7) Discontinuation of any investigational drug or treatment at least 3 months prior to study Day 0 or as per washout requirements from previous protocol. 8) Willingness and ability to comply with the protocol requirements for the duration of the study. 9) Written informed consent, given prior to any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw his/her consent at any time without prejudice to future medical care. |
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E.4 | Principal exclusion criteria |
1) Hypersensitivity to efalizumab or to any of the excipients 2) Current use of any prohibited therapy (systemic treatments for psoriasis, immunosuppressive drugs, any other experimental drug, etc) 3) Previous or current exposure to Raptiva® 4) History of or ongoing alcohol or drug abuse 5) Weight > 120 kg 6) History of or an ongoing opportunistic infection (e.g. systemic fungal infection, parasites) or any other serious infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded. 7) Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening, and any subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded. 8) History of active or latent tuberculosis within one year prior to screening (to be determined by assessment according to national and/or local recommendation). 9) Presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled. 10) Pregnancy or breast-feeding 11) Diagnosis of hepatic cirrhosis, regardless of cause or severity 12) History of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a WBC count <4,000 cells/μL or >14,000 cells/μL, a haematocrit (HCT) <30% or a haemoglobin (Hgb) level <11 g/dL, a platelet count <150,000 cells/μL 13) Hepatic enzyme levels ≥3 times the upper limit of normal or serum creatinine level ≥2 times the upper limit of normal 14) Vaccination with a live virus or live bacteria vaccine within the 14 days prior to the first dose of Raptiva® 15) Any medical condition that, in the judgment of the Investigator, would jeopardise the subject’s safety following exposure to study drug (Raptiva ® or placebo equivalent) or would significantly interfere with the Subject’s ability to comply with the provisions of this protocol. 16) Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant for of psoriasis. 17) Immunodeficiencies. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving at week 12 a static Physician Global Assessment with Hand and Foot (PGA – H&F) rating of clear, almost clear, or mild, in subjects randomised to Raptiva ® as compared to placebo. |
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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 | 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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | Information not present in EudraCT |
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 |
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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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For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all trial sites |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |