A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).

Official Title
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A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: KP-413 Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck. Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study. Exclusion Criteria: Female who is pregnant, nursing an infant, or planning a pregnancy during the study period. Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs. Presence of a concurrent skin condition that could interfere with assessment of treatment. Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Experimental: 3% KP-413 Ointment<br> | Drug: KP-413 Ointment<br>* Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.<br>|
| Experimental: 1% KP-413 Ointment<br> | Drug: KP-413 Ointment<br>* Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: KP-413 Ointment<br>* Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Severity Score(IGSS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of KP-413 |  | 6 weeks | 
| Signs and Symptoms of AD |  | 4 weeks | 
| Subject's Numerical Rating Scale(NRS) of Pruritus Score |  | 4 weeks | 
| Percent of AD-affected body surface area (BSA) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis