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 assess the efficacy of SRD441 ointment in treating acute exacerbations of atopic dermatitis |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety and dermal toleration of repeated doses of SRD441 ointment in subjects with atopic dermatitis • To assess systemic exposure of SRD441 ointment following dermal application • To assess the effect on biomarker activity of SRD441 ointment • To explore the efficacy of SRD441 ointment at preventing / delaying AD exacerbation occurrence • To explore the effect on quality of life of treatment with SRD441 ointment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female subjects aged 18 or over. • Subjects with history of AD diagnosed by an appropriately qualified dermatologist. • All female subjects of childbearing potential and male subjects with female partners of childbearing potential (defined as not surgically sterilised or post-menopausal for 2 years) must use a form of highly effective contraception. Highly effective contraception is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. • Subjects with a current exacerbation of their AD. Exacerbation of AD in this study is defined as the subject requiring a “step-up” of their standard AD therapy (e.g., a subject who is ordinarily “controlled” on an emollient or moisturiser. A “step-up” will be the need for that subject to switch to, or add, a low or medium dose topical steroid or topical TCI to their current therapy to control their AD. This will be patient reported and prior written evidence of the “step-up” in medical notes is not required). • Subjects must have an IGA score of 2 or 3 at randomisation with affected area(s) ≤ 20% total BSA. • Satisfactory medical assessment with no clinically significant or relevant abnormalities of medical history, physical examination, vital signs, electrocardiogram [ECG], and clinical or laboratory evaluation, other than a history of atopy. • The subject must understand and be able, willing and likely to fully comply with study procedures and restrictions. |
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E.4 | Principal exclusion criteria |
• Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. • Subjects whose atopic dermatitis is predominantly affecting the hands • Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. • Subjects with severe AD as defined as a score 4 on the IGA. • Subjects with systemic bacterial, viral and/ or mycotic infection • Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study. • Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison between SRD441 and vehicle ointment in Investigator’s Global Assessment (IGA) of individual atopic dermatitis signs at Day 21 |
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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 | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |