E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe chronic plaque psoriasis |
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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 |
|
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 establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis |
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E.2.2 | Secondary objectives of the trial |
To determine the pharmacodynamic effect of alefacept on peripheral blood lymphocygtes and lymphocyte subjects when administered to adolescent subjects.
To determine the pharmacokinetics of alefacept when administered to adolescent subjects in a subset of the study population of adolescent subjects
Additional objective: To determine the efficacy of alefacept when administered to adolescent subjects with moderate to severe psoriasis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent / (Assent, if applicable) and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). Guardian or proxy consenter informed consent has been obtained for pediatric studies.
2. Subject is male or female, between and inclusive of 12-17 years of age at baseline.
3. Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area (where the subject’s hand [palm plus digits] represents approximately 1% of the body surface area).
4. Subject is a candidate for systemic treatment or phototherapy.
5. Subject is in good health (as determined by the investigator) and alefacept is not contraindicated.
6. Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening.
7. Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study.
8. Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT and AST.
9. Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose.
10. Subject meets medication washout requirements and agrees to follow medication restrictions during the study (see Appendix 1).
11. Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits. |
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E.4 | Principal exclusion criteria |
1. Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis (e.g., erythrodermic, guttate, pustular or palmar/plantar pustulosis).
2. Subject has a known hypersensitivity to alefacept or any excipient of the study medication.
3. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 12 weeks prior to the first dose of study drug.
4. Subject has a fever (body temperature ≥ 38°C (or >37 ºC for sites in Latvia)) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug.
5. Subject is known to be positive for HIV antibodies.
6. Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening.
7. Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening.
8. Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug.
9. Subject is currently enrolled in any other study and/or previous participation in this study.
10. Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks.
11. Subject has a history of malignancy (other than non-melanoma skin cancers).
12. Subject has a chronic condition (e.g., diabetes or hypertension) which is not well controlled.
13. Subject is pregnant or nursing.
14. Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety.
15. Subject has a history of severe allergic or anaphylactic reactions. |
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| 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 | 8 |
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 | 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
| |
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 | 10 |
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 | 10 |