Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD

Study Overview
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Brief Summary
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This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis

Detailed Description
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This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis. Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle. Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.

Official Title
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A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: ATx201
* Drug: ATx201 OINTMENT vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (main ones): Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp) Age ≥12 and <60 years Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1. Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents. Normally active and otherwise in good health by medical history and physical examination Exclusion Criteria (main ones): Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator) Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone Enrollment in an ATx201 study in the previous 6 months Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex) Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk Unable or unwilling to comply with study procedures Exposure to any IP within 30 days prior to randomization There are also some specific criteria related to prior or concomitant therapy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 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
Interventional Model Description: Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATx201 OINTMENT 4%<br>ATx201 OINTMENT 4% | Drug: ATx201<br>* Topical<br>* Other names: ATx201 OINTMENT;|
| Experimental: ATx201 OINTMENT 7%<br>ATx201 OINTMENT 7% | Drug: ATx201<br>* Topical<br>* Other names: ATx201 OINTMENT;|
| Experimental: ATx201 OINTMENT vehicle<br>ATx201 OINTMENT vehicle | Drug: ATx201 OINTMENT vehicle<br>* ATx201 OINTMENT vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI) | EASI mean change from baseline at Week 6 | Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) success | IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline | Baseline to Week 6 | 
| change from baseline in Investigator Global Assessment (IGA) scoring | Distribution of IGA scores and change from baseline | Baseline to Week 6 | 
| Mean change from baseline in Target lesion Total Sign Score (TSS) | Target lesion TSS mean change from baseline | Baseline to Week 6 |