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ADX-629 for Atopic Dermatitis
Phase 2
Waitlist Available
Research Sponsored by Aldeyra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 90
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and effectiveness of a new drug to treat adults with atopic dermatitis.
Who is the study for?
This trial is for adults over 18 with mild to severe atopic dermatitis, which they've had for at least six months. Participants must not be pregnant or breastfeeding and should agree to use effective contraception during the trial. People with unstable chronic diseases, significant health abnormalities, or serious kidney disease are excluded.
What is being tested?
The study is testing ADX-629's safety and effectiveness in treating atopic dermatitis both alone and alongside standard care. It's a Phase 2 trial involving multiple centers where all participants will openly receive the treatment without being compared to a control group.
What are the potential side effects?
Specific side effects of ADX-629 aren't listed here, but generally, treatments like this could cause skin reactions, irritation or discomfort at the application site if topical, as well as potential systemic effects depending on how it works in the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin condition is diagnosed as atopic dermatitis with a severity score of 2 or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is low, with an eGFR of 45 ml/min/1.73m^2 or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Event (AE) Query
Secondary study objectives
Investigator Global Assessment (IGA) Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADX-629Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADX-629 (Open-label)
2023
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Aldeyra Therapeutics, Inc.Lead Sponsor
33 Previous Clinical Trials
4,670 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My skin condition is diagnosed as atopic dermatitis with a severity score of 2 or more.You have had atopic dermatitis for at least 6 months according to American Academy of Dermatology criteria.My kidney function is low, with an eGFR of 45 ml/min/1.73m^2 or less.
Research Study Groups:
This trial has the following groups:- Group 1: ADX-629
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.