Atopic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: SRD441 ointment
Pharmaceutical Form: Ointment
Current Sponsor code: SRD441
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical
Sponsors
Serentis Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the efficacy of SRD441 ointment in treating acute exacerbations of atopic dermatitis;Secondary Objective: • 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;Primary end point(s): Comparison between SRD441 and vehicle ointment in Investigator’s Global Assessment (IGA) of individual atopic dermatitis signs at Day 21 | — |
Countries
Bulgaria, Finland, Germany
Outcome results
None listed