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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ADX-629 (Open-label)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05717920

ADX-629-ATD-001

Details and patient eligibility

About

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.

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

ADX-629

Experimental group

Treatment:

Drug: ADX-629 (Open-label)