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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: ADX-629 (Open-label)

• Registration Number: NCT05717920
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Study Start: 2023-02-15
• Primary Completion: 2023-11-21
• Study Completion: 2023-11-21
• Disposition First Posted: 2024-04-17
• Status Verified: 2024-10
• Disposition First Submitted: 2024-10-30
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADX-629	ADX-629 (Open-label)	-

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE) Query	From Day 1 to Day 90	Incidence and severity of AEs

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) Score	From Day 1 to Day 90	Change from Baseline in IGA Score

Trial Locations

Locations (1)

Bexley Dermatology Research; 🇺🇸 Bexley, Ohio, United States