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 | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
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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 objective of this study is to compare the efficacy and safety of a tacrolimus ointment 0.03% regimen to a vehicle-based regimen administered to control atopic dermatitis in paediatric patients over a period of 12 months. |
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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 |
1) Patient may be male or female of any ethnic group. 2) Patient is aged 2 to 15 years and suffers from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3). 3) Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well 4) Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study. 5) Patient meets the following wash-out criteria at Open Label Day 1 visit: Pre-Study Therapy Restrictions - Topical corticosteroids, topical immunomodulators (except for intranasal/inhaled corticosteroids) = 3 days wash-out period prior to Open Label Day 1 - Systemic corticosteroids (for the treatment of AD only) = 5 days wash-out period prior to Open Label Day 1 - Systemic non-steroidal immunosuppressants (e.g. ciclosporine, methotrexate) = 2 weeks wash-out period prior to Open Label Day 1 - Other investigational drugs = 4 weeks wash-out period prior to Open Label Day 1 - Light Treatments (UVA, UVB) = 6 weeks wash-out period prior to Open Label Day 1 6) Patient and legal representative(s) agree that the patient will not take for the complete study period any medication or therapy prohibited by the protocol, 7) Patient is able to reach the centre within 2 days in case of a disease exacerbation.
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E.4 | Principal exclusion criteria |
1) Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma. 2) Patient is pregnant or breast-feeding. 3) Patient has a clinically significant skin infection on the affected (and to be treated) area. 4) Patient has a known hypersensitivity to macrolides or any excipient of the ointment. 5) Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one. 6) Any form of substance abuse (including drug or alcohol abuse) psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator. 7) Patient is known to be HIV positive.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of disease exacerbations requiring a “substantial therapeutic intervention” during the disease control period. A “substantial therapeutic intervention” is defined as an exacerbation treatment of > 7 days scheduled relative to Exacerbation Day 1 visit and an IGA 3-5 at Exacerbation Day 1 visit.
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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 | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Open: Pre-Randomisation Open Label Period and Disease Exacerbation Period(s) |
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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 | 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 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 | 6 |
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 | 6 |