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 |
To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The subject is a male or female, 18 years of age or older
2. The subject has a clinical diagnosis of Atopic dermatitis according to the Hanifin and Rajka criteria
3. The subject has at least two equivalent symmetrical target lesions of Atopic dermatitis localized on comparable body areas (left/right) which: - Are between 20 and 200 cm² (approximately 1% of BSA) - Have not more that a 2-fold difference in size - Are not located on the hands, feet, genitalia or face - Present a total severity score of at least 6/15 (total score defined as the sum of erythema, papulation/induration, oozing/crusting, excoriation, lichenification) with oozing/crusting score ≤ 1. - Are of similar severity (severity of the two target lesions does not differ by more than 1 point based on the TSS score ) - Have a Pruritus score ≥ 2
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E.4 | Principal exclusion criteria |
1. The subject is a pregnant or lactating female
2. The subject is a female who intends to conceive a child within 2 months following baseline visit
3. The subject has history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget’s disease, adrenal insufficiency, hyperthyroidism…)
4. The subject has signs and symptoms of urinary stones
5. The subject has had urinary stones since the past 5 year before screening visit
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary criterion is the Total Sum Score on target lesion (sum of individual clinical scores of erythema, excoriation, papulation/induration, oozing/crusting and lichenification) |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |