E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic 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 |
The main objective of this study is to assess the efficacy of mapracorat ointment in concentrations of 0.01%, 0.03%, and 0.1% in subjects with AD compared to vehicle.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are:
• To evaluate the safety and tolerability of mapracorat ointment in concentrations of 0.01%, 0.03%, and 0.1% • To assess the dose-response relationship of mapracorat after topical, non-occlusive application of concentrations of 0.01%, 0.03%, and 0.1% • To assess the systemic exposure of mapracorat after topical, non-occlusive application of concentrations of 0.01%, 0.03%, and 0.1%
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must fulfill all of the following criteria before inclusion in the study:
1 Signed written informed consent 2 Male or female out-patient subject 18 to 65 years of age at screening (female subject either using an accepted effective method of contraception (failure rate of < 1%,) or of non-childbearing potential, (this means post menopausal -one year without menstrual period)) 3 Diagnosis of AD according to Hanifin and Rajka Criteria (Hanifin and Rajka 1980) 4 Static Investigator’s Global Assessment score ≥ 3, corresponding to at least moderate AD at screening and start of treatment 5 Atopic dermatitis involving a minimum of 5% body surface area at screening and start of treatment 6 Willingness of subject to follow all study procedures 7 Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
All parameters will be determined during the screening and baseline visit prior to first administration of the investigational product if not otherwise stated.
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E.4 | Principal exclusion criteria |
Subjects are to be excluded from the study if they display any of the following criteria:
Medical and surgical history 1 Pregnancy or lactation 2 Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results 3 Clinically manifested immunosuppressive disorder or known history of malignant disease 4 Known hypersensitivity to any of the constituents or excipients of the investigational product (e.g. paraffin) or history of relevant drug and/or food allergies Medication, drug use and special behavioral patterns 5 Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study • At least 3 months have passed since any systemic interferon, immunomodulating or immunosuppressive treatment (excluding systemic AD therapy as listed in the following point) • At least 1 month has passed since any use of systemic AD therapy, in particular systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy • At least 2 weeks have passed since any local AD therapy, e.g. corticosteroids or topical immunomodulators • At least 2 weeks have passed since systemic or topical antibiotics • At least 1 week has passed since use of local anti-itch therapy (for example atopiclair)
Physical examination 6 Concomitant medical or dermatological disorder(s), which could interfere with the investigator’s ability to evaluate the subject’s response to the investigational product, e.g. chicken pox, impetigo, corticosteroid-induced perioral dermatitis, tinea corporis/tinea intertriginosa, recurrent active herpes simplex, head lice or scabies Laboratory examination 7 Clinically relevant deviation in values for biochemistry, hematology, coagulation or urinalysis as judged by the investigator
Other 8 Mental handicap, legal incapacity or limited legal capacity leading to inability to give informed consent, subject is institutionalized because of legal or regulatory order 9 Subject is a dependent person, this means a relative/family member of the investigator and/or a member of the investigator’s staff 10 Participation in another clinical research study within 4 weeks before enrollment in this study. 11 Previous assignment to treatment during this study
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is eczema area and severity index (EASI) |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
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 |
Tolerability; Quality of life |
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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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 | 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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The end of the trial is defined as the last contact with the last subject who participated in the study. |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |