Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacodynamics, Safety, Tolerability and Efficacy of Omiganan BID in Patients With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Omiganan
* Drug: Omiganan
* Drug: Omiganan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis; Confirmed AD diagnosis; Symptoms present for at least 1 year; EASI between 7.1 - 50.0, inclusive at screening; 2-20% body surface area (BSA) affected at screening; Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg; Able to participate and willing to give written informed consent and to comply with the study restrictions; Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose. Exclusion Criteria: Any current and / or recurrent clinical significant skin condition other than AD; Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug); Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area; Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment; Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients; Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year; Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omiganan 1%<br> | Drug: Omiganan<br>* Omiganan 1%<br>|
| Experimental: Omiganan 1.75%<br> | Drug: Omiganan<br>* Omiganan 1.75%<br>|
| Experimental: Omiganan 2.5%<br> | Drug: Omiganan<br>* Omiganan 2.5%<br>|
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation (oSCORAD) | oSCORAD Assessment | Within 7 Weeks | 
| Clinical Evaluation (EASI) | EASI Assessment | Within 7 Weeks | 
| Clinical Evaluation (IGA) | IGA Assessment | Within 7 Weeks | 
| Patient-Orientated Outcome Measure (POEM) | Patient Assessment by collecting POEM | Within 7 Weeks | 
| Dermatology Life Quality Index (DLQI) | Assessment of health-related quality of life by measuring DLQI | Within 7 Weeks | 
| eDiary | Singe-Question assessment of pruritus and sleeplessness | Within 4 Weeks | 
| Clinical Photography | Whole body photograph for qualitative and observational record | Within 7 Weeks | 
| Pharmacodynamics (Biomarkers) | Local biomarkers sequencing | Within 7 Weeks | 
| Pharmacodynamics (Microbiome) | Microbiome analysis | Within 7 Weeks | 
| Pharmacodynamics (Microbiology) | Microbiology analysis | Within 7 Weeks | 
| Pharmacodynamics (TEWL) | Transepidermal water-loss assessment | Within 7 Weeks | 
| Pharmacodynamics (Thermography) | Skin temperature measurements will be taken | Within 7 Weeks | 
| Pharmacodynamics (TAP) | Analysis of biomarkers captured by Transdermal Analysis Patch | Within 7 Weeks | 
| Pharmacodynamics (Cytokines) | Cytokine assessment via blood evaluation | Within 7 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (AE) | Adverse Events will be collected throughout the study | Within 7 Weeks | 
| Safety (Vital Signs) | Vital Signs will be collected throughout the study | Within 7 Weeks | 
| Safety (Clinical Laboratory Tests) | Lab samples collected in various timepoints within the study | Within 7 Weeks | 
| Safety (ECG) | ECGs collected before beginning and end of study | Within 7 Weeks |