Back to resultsA Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Part 1 ADX-629 (Open-label)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, atopic, adaptive, Aldeyra, ADX-629, Reactive aldehyde species (RASP)
Eligibility Criteria
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
Sites / Locations
- Bexley Dermatology ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADX-629
Arm Description
Outcomes
Primary Outcome Measures
Adverse Event (AE) Query
Incidence and severity of AEs
Secondary Outcome Measures
Investigator Global Assessment (IGA) Score
Change from Baseline in IGA Score
Full Information
NCT ID
NCT05717920
First Posted
January 25, 2023
Last Updated
March 7, 2023
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05717920
Brief Title
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
Official Title
The ADRO Trial: An Adaptive, 2-Part, Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Adults With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, atopic, adaptive, Aldeyra, ADX-629, Reactive aldehyde species (RASP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Part 1 is an open-label trial.
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADX-629
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Part 1 ADX-629 (Open-label)
Intervention Description
ADX-629 (250 mg) administered BID for 90 days
Primary Outcome Measure Information:
Title
Adverse Event (AE) Query
Description
Incidence and severity of AEs
Time Frame
From Day 1 to Day 90
Secondary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) Score
Description
Change from Baseline in IGA Score
Time Frame
From Day 1 to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bill Cavanagh
Phone
781-761-4904
Email
bcavanagh@aldeyra.com
Facility Information:
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Zirwas, MD
Phone
614-947-1716
Email
ablankenbuhler@docsdermgroup.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
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