A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)

Study Overview
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Brief Summary
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A Phase 2, multicenter, adaptive 2-part clinical trial designed to evaluate the safety and efficacy of ADX-629 alone and in combination with standard-of-care in adults with atopic dermatitis.

Detailed Description
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The trial is divided into 2 parts; the first part of the trial (Part 1) is open label, and the second part (Part 2) is randomized, double-blind, and placebo controlled. In Part 1, approximately 10 subjects will receive open-label ADX-629 twice daily for 90 days. In Part 2, approximately 40 subjects will be randomized to receive either ADX-629 or matching placebo twice daily for 90 days. Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Official Title
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The ADRO Trial: An Adaptive, 2-Part, Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Adults With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Part 1 ADX-629 (Open-label)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age History of atopic dermatitis, according to American Academy of Dermatology criteria, that has been present for at least 6 months Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable Exclusion Criteria: Presence of clinically significant kidney disease or an estimated gloverular filtration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 during screening History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-629<br> | Drug: Part 1 ADX-629 (Open-label)<br>* ADX-629 (250 mg) administered BID for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event (AE) Query | Incidence and severity of AEs | From Day 1 to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) Score | Change from Baseline in IGA Score | From Day 1 to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eczema, atopic, adaptive, Aldeyra, ADX-629, Reactive aldehyde species (RASP)