E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy |
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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 |
To assess the safety and efficacy of 12 to 24-week course of BAL4079 in patients with chronic hand dermatitis refractory to topical therapy previously treated with BAL4079 or placebo in study BAP00089 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Written informed consent provided - Male patients, and female patients either without childbearing potential or of childbearing potential and using appropriate contraception, who participated in study BAP00089 and were either: a) Responders (rated clear or almost clear according to the PGA at the end of treatment), and relapsing within 24 weeks after the end of treatment (TLSS score ≥ 75% that of baseline in BAP00089), or b) Non-responders, rated mild or moderate according to the PGA after 24 weeks of treatment
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E.4 | Principal exclusion criteria |
- Female patients who are pregnant or who plan to become pregnant or who are breast feeding - Female patients of child-bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously under supervision of the investigator or a gynecologist. - Patients treated with systemic therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment (1) (use of inhald steroids is permitted) - Patients treated with phototherapy UVB, PUVA, Grenz rays, or X-rays within four weeks before start of trial treatment (1) - Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety or the evaluation of the study, including chronic hard failure, recent myocardial infraction (chest pain within the last three month with changes in ECG and/or increased cardiac enzymes), chronic infection, chronic renal failure, chronic liver failure, unstable hypothyroidism, chronic biliary disease, uncontrolled diabetes mellitus - Patients with ALT and /or AST >2.5x ULN - Patients with fasting triglyceridermia > 2x ULN - Patients with cholesterol > 2X ULN and /or LDL/cholesterol > 2x ULN - Patients with hemoglobin <LLN - Patients receiving drugs with potential for drug-drug interaction such as systemic tetracyclines, ketoconazole, erythromycin or claritromycin, cyclosporine, simvastatin, or St. John’s wart within one week or receiving systemic intraconozole within 2 weeks, before start of trial treatment.(1) - Patients receiving topical retinoids, macrolides, tacrolimus,or pimecrolimus on affected areas or taking vitamin supplements containing > 2000 IU vitamin A within one week before start of trial treatment (1) - Patients included in the study of any other investigational drug (except alitretinoin) within 2 months before start of trial treatment - Patients with a sccore of 20 or more on the CES-D depression scale at screening, or with a history of major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia)
(1) Patients may be enrolled after a corresponding wash-out period (see section 4.4) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Physician's Global Assessment (PGA) of efficacy |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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) | 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.8.5 | The trial involves multiple Member States | Yes |
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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |