A randomized, double-blind, placebo controlled study to assess the pharmacodynamics, safety/tolerability and efficacy of omiganan in patients with mild to moderate atopic dermatitis

Phase 2

Completed

• Conditions: atopic dermatitis; eczema; 10014982

• Registration Number: NL-OMON42598
• Lead Sponsor: Cutanea Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Male and female subjects with mild to moderate AD 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, haematology, blood chemistry, and urinalysis.
2. AD diagnosed by the physician / medical specialist and that has been present for at least 1 year.
3. At least one of the antecubital fossae must have an affected body surface area (BSA) of 0.5% with active dermatitis characterized by erythema and squamae at screening and end of the run-in period
4. Pruritus VAS score of target lesion of >=30 at screening and end of the run-in period
5. oSCORAD-score of total body <= 40.
6. 2-15% body surface area (BSA) involved with AD lesions at screening.
7. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria

1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.;2. 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.;3. Tanning due to sunbathing, excessive sun exposure, or a tanning booth within 3 weeks of enrollment.;4. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.;5. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.;6. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.;7. Unwillingness or inability to comply with the study protocol for any other reason.;Other qualifying criteria:
1. Subjects and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 3 months after the last dose (section 4.4.1).
2. Subjects must not have received treatments for AD within the intervals for the following medications:
a. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic immunosuppressants: 4 weeks
b. Phototherapy: 3 weeks
c. Topical calcineurin-inhibitors: 10 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic endpoints<br /><br>Pharmacodynamic effects of CLS001 on the target lesion will be assessed at the<br /><br>time points indicated in the Visit and Assessment Schedule (Table 1).<br /><br><br /><br>- Local (biopsy) biomarkers (IgE, IFN- &gamma; IL-1b, IL4, IL-6, IL-8, IL-9, IL-10,<br /><br>IL-13, IL-18, IL-31, TARC, eotaxin, oncostatin, TLR-2, TSLP, fillagrin)<br /><br>- Microbiome of skin lesion<br /><br>- Bacterial colonization of skin lesions (S. aureus) including biomarkers<br /><br>(enterotoxins)<br /><br>- Transepidermal water loss of lesional and non-lesional skin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability in AD patients<br /><br><br /><br>Adverse events (AE) will be collected throughout the study, at every study<br /><br>visit. Laboratory safety testing, 12-Lead ECGs and vital signs will be<br /><br>performed and measured multiple times during the course the study according to<br /><br>the Visit and Assessment Schedule. Skin tolerance and cosmetic scores by<br /><br>patients will be collected on day 28.<br /><br><br /><br>Efficacy endpoints<br /><br><br /><br>Change from baseline to each time point of measurement during each treatment<br /><br>period for the following assessments:<br /><br>• Clinical assessment of lesion on-site with local objective SCORAD and<br /><br>pruritus VAS<br /><br>• Lesion size and morphology assessment by standardized clinical photography<br /><br>and 3D photography</p><br>