Atopic Dermatitis
Conditions
Keywords
eczema, atopic, adaptive, Aldeyra, ADX-629, Reactive aldehyde species (RASP)
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.
Interventions
DRUGADX-629 (Open-label)
ADX-629 (250 mg) administered twice daily for 90 days
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Part 1 is an open-label trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) Query | From Day 1 to Day 90 | Incidence and severity of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Score | From Day 1 to Day 90 | Change from Baseline in IGA Score |
Countries
United States
Outcome results
None listed