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 | 9.1 |
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 primary objective is to evaluate the efficacy and safety of 2% AVT-02 UE ointment in subjects with atopic dermatitis compared to placebo as assessed by modified EASI of marker areas and safety data during a 4 weeks treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the efficacy and tolerability as assessed by IGA, modified EASI50, physicians’ and subjects’ assessment of tolerability, laboratory parameter, AEs and photo documentation (selected site only) as well as (for a subset of 35 subjects) by immune histological markers in skin biopsies. PK measures will be performed in 8 subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male, aged between 18 to 75 years Subjects must have a diagnosis of mild to moderate atopic dermatitis (IGA > 1 and < 4 ) > 2 symmetrical eczema areas on the extremities each of at least 12 cm2 with a modified EASI severity score of the test area (sum of erythema, induration/population, excoriation and lichenification) > 6 and > 60 % afflicted with atopic dermatitis Written informed consent
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E.4 | Principal exclusion criteria |
Any condition other than atopic dermatitis (and related disorders) or treatment that may interfere with the skin barrier function Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune measures) Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade) Administration of any biologic within 3 months prior to study entry Administration of any other systemic drugs for atopic dermatitis (e.g. corticosteroids, cyclosporine) within 30 days prior to study entry Administration of any topical drugs for atopic dermatitis (e.g. glucocorticoseroids, calcineurin inhibitors) within 14 days prior to study entry Administration of antihistamines within 7 days prior to study entry Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry Administration of any topical anti-inflammatory drug within 14 days prior to study entry Clinically relevant co-morbidity Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment (including Unguentum emulsificans) History or presence of malignant disease (other than surgically removed b-cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis) Immunotherapy prior to and during the study Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study HIV infection (has to be excluded by laboratory test prior to randomization) Other active infectious diseases Major surgery 4 weeks prior to inclusion into study Vaccination with 6 days prior to enrolment and during the study Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study Subjects with partner of child-bearing potential and their partners should use barrier contraception e.g. condoms. The partners of subjects should also use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.barrier methods of contraception such as condoms, diaphragm, or the cervical cap. Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial Participation in any other clinical trial within 4 weeks prior or during this trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is change compared to baseline in the modified EASI at week 4. The endpoint will be compared between the two treatment groups using the Student’s t-test for related samples at <0.05 level of significance. |
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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 | Yes |
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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
intraindividual-comparison |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |