A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
Atopic Dermatitis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 8 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 Investigator Global Assessment (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 glomerular 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
ADX-629
Not reported in this registry record.
Drug: ADX-629 (Open-label)
ADX-629 (Open-label) DRUG
ADX-629 (250 mg) administered twice daily for 90 days
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number of Subjects With Serious Adverse Events
Time frame: The safety assessment period was approximately 15 weeks.
The proportion of subjects that experience at least one serious adverse event
Secondary measures
Proportion of Subjects Achieving ≥ 4 Point Improvement in the Peak Pruritus Numerical Rating Scale
Time frame: The efficacy assessment period was from Day 1 to Day 90.
The Peak Pruritus Numerical Rating Scale is an eleven-point scale (0 = no itch, 10 = worst itch imaginable).
Proportion of Subjects With a ≥ 50% Improvement in Eczema Area and Severity Index (EASI) Score at Day 90
Time frame: The efficacy assessment period was Day 90.
The total EASI score ranges from 0 to 72, with a higher score indicating more severe disease.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Bexley Dermatology ResearchBexley, Ohio, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Study start
- Feb 15, 2023 Actual
- Primary completion
- Nov 21, 2023 Actual
- Study completion
- Nov 21, 2023 Actual
- First posted
- Feb 8, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026