E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with psoriasis vulgaris (plaque psoriasis) |
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MedDRA Classification |
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 objective of the study is to determine if P-38, MK2, MSK-1 levels and TNF-a in lesional psoriatic skin are normalized by Adalimumab |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to investigate if changes in inflammatory cytokine levels and TNF-a will be correlated with clinical response (PASI 75, success according to PGA). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and female more than or equal to 18 years of age Diagnosis of plaque psoriasis according to the Investigator Moderate or severe psoriasis according to the PGA (PGA more than or equal to 4, i.e. classified as moderate, moderate to severe, or severe) Having a PASI more than or equal to 10 and BSA more than or equal to 10, and being eligible to biological anti-psoriatic therapy in the opinion of the investigator A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)] Use of reliable method of contraception e.g. intra-uterine devices or hormone contraceptives (oral, implantable, or injectable) by all female patients of childbearing potential during the entire study and 150 days after cessation of study medication. Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections. Able and willing to give written informed consent/power of attorney and to comply with the requirements of the study protocol.
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E.4 | Principal exclusion criteria |
Use of topical anti-psoriatic therapy, e.g. topical vitamin D derivatives or topical corticosteroids, and UVB therapy 2 weeks prior to screening and during the 12 weeks’ treatment phase Use of psoralen ultraviolet A therapy (PUVA) or systemic corticosteroids 4 weeks prior to screening and during the 12 weeks’ treatment phase Use of biological therapies, e.g. efalizumab, etanercept, or infliximab, 12 weeks prior to screening and during the 12 weeks’ treatment phase Systemic therapies known to exacerbate psoriaisis, e.g. B-blocking agents, lithium, or chloroquines, during the study Positive serology for hepatitis B or C indicating active infection Immuno-compromised conditions or history of HIV. History of listeriosis, history of histoplasmosis, active tuberculosis (TB), persistent chronic or active infections requiring hospitalisation and/or treatment with intravenous (i.v.) antibiotics, i.v. antivirals, or i.v. antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to screening. Subjects with latent TB (positive purified protein derivative (PPD) skin test and/or chest X-ray indicative for TB) History of malignant melanoma History of malignancy within the previous 5 years, other than malignant melanoma or a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the study. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. There should be at least a 150 days’ period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential. History of clinically significant drug or alcohol abuse in the last year History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease Investigational biological and chemical agents within 6 months prior to screening. Allergy to investigational product or its contents or latex (found in the protective cover of the syringe needle). The investigator considers the subject, for any reason, to be unacceptable for study participation.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving normalized TNF-a, P-38, MK2, and MSK1 levels in psoriatic skin lesions, based on skin biopsies taken at day 84 |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 |
mode of action/pharmacodynamics |
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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 | No |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
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 patient last follow-up visit (if follow-up is applicable) |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |