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

Aldeyra Therapeutics, Inc.8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

ADX-629 (Open-label)DRUG

ADX-629 (250 mg) administered twice daily for 90 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bexley Dermatology Research

Bexley, Ohio, United States

Outcomes

Primary Outcomes

Adverse Event (AE) Query

Incidence and severity of AEs

Time frame: From Day 1 to Day 90

Secondary Outcomes

Investigator Global Assessment (IGA) Score

Change from Baseline in IGA Score

Time frame: From Day 1 to Day 90

Data from ClinicalTrials.gov

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