CT 327 in the Treatment of Atopic Dermatitis

Study Overview
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Brief Summary
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This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily for 14 days on specific lesions of AD and safety and symptoms of AD will be assessed throughout the treatment period.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of the Safety and Efficacy of CT 327, Pegylated K-252, Formulated as a Cream, When Administered Twice Daily for 14 Days to Subjects With Mild-to-Moderate Atopic Dermatitis

Conditions
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Mild to Moderate Atopic Dermatitis

Intervention / Treatment
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* Drug: placebo
* Drug: CT 327


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female subjects aged >18 year Written informed consent Mild to moderate AD at baseline (EASI score of at least 2 or 3) Active AD (visible eczema, erythema and pruritus) Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends) Exclusion Criteria: If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch If female, are pregnant or lactating, or intend to become pregnant during the study period Allergy to test drug or excipients Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light). Presence of major medical illness requiring systemic therapy including cancers Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses Any clinical relevant ECG abnormality Have any clinically significant abnormal clinical laboratory test results at screening Received any investigational drug or taking part in any clinical study within three months prior to this study History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo only<br>Subjects will apply placebo cream to all 4 target lesions | Drug: placebo<br>* 0.5 g (w/w) placebo cream applied to each target lesion twice daily<br>|
| Active Comparator: Active plus placebo<br>Subjects will receive CT 327 on 2 of 4 target lesions located on one side of their body. On the remaining 2 target lesions on the other side of their body, placebo will be applied. | Drug: CT 327<br>* 0.5 g CT 327 cream will be applied to 2 target lesions twice daily 0.5 g placebo cream will be applied to remaining 2 target lesions twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of CT 327 vs Placebo in terms of improvements from baseline on Modified Eczema Area Severity Index (mEASI) score: Proportion of subjects with a reduction in mEASI-score of ≥ 50% on day 14 |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of a 14-days treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-EASI-score of > 75% on day 14 |  | 14 days |