E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy |
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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 | 10066695 |
E.1.2 | Term | Chronic hand dermatitis |
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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 assess the safety of alitretinoin |
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E.2.2 | Secondary objectives of the trial |
To determine the efficacy of the alitretinoin in patients with relapsed refractory CHaD, who have responded to previous treatment in clinical trials involving alitretinoin, based on: - proportion of patients with response (Physician’s Global Assessment rating of clear or almost clear); - proportion of patients with at least partial response (Physician’s Global Assessment rating of clear, almost clear or mild); - Patient’s Global Assessment (PaGA) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male patients, or female patients if post-menopausal, or hysterectomized, or if pre-menopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist - Aged 18 to 80 years - Previous participation in the therapeutic trials BAP00089 or BAP00200, involving oral alitretinoin for chronic hand dermatitis - Relapse with development of a CHaD , defined as 75% of the mTLSS of baseline of the initial study, despite ongoing treatment with topical therapy including topical steroids, or insufficient treatment response - Written informed consent provided |
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E.4 | Principal exclusion criteria |
- Patients unable to comply with the requirements of the study - Female patients who are pregnant or who plan to become pregnant or who are breast feeding - Female patients of childbearing 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 whose disease is adequately controlled by standard non-medicated therapy (skin moisturization and protection, avoidance of irritants and allergens) and standard topical corticosteroid therapy - Patients who have participated in study BAP00091 - Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil - Patients with known clinically relevant allergic contact dermatitis of the hands, as demonstrated by a prior positive patch test, who have not made a reasonable effort to avoid relevant contact allergens - patients presenting with a) psoriasis lesions (including palmo-plantar psoriasis, b) atopic dermatitis lesions requiring medicated treatment, c) acute (non-chronic) episodes of pompholyx/ dyshydrosis or of contact dermatitis d) active bacterial, fungal or viral infections of the hands - 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 heart failure, recent myocardial infarction (chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes), 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 triglyceridemia > 1,5x ULN - Patients with cholesterol >1,5 x ULN and/or LDL/cholesterol > 1,5 x ULN - Patients with hemoglobin <0,9 LLN - Patients receiving drugs with a potential for drug-drug interaction such as systemic retinoids > 2000IU vitamin A, tetracyclines, ketoconazole, erythromycin or clarithromycin, simvastatin, or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment - Patients included in the study of an investigational drug other than alitretinoin within 2 months before start of trial treatment - Patients with an active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia) |
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E.5 End points |
E.5.1 | Primary end point(s) |
For safety: Adverse Events
For efficacy: - Proportion of patients with response at end of therapy (PGA rating of clear or almost clear) - Proportion of patients with at least partial response at end of therapy (PGA rating of clear, almost clear or mild) - Time from start of treatment to first PGA assessment of “clear” or “almost clear” (time to response) - Patient’s global assessment at the end of therapy |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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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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 | 2 |
E.8.9.1 | In the Member State concerned days | |