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NCT05717920 Clinical Trial

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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05717920
Other study ID # ADX-629-ATD-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 15, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Aldeyra Therapeutics, Inc.
Contact Bill Cavanagh
Phone 781-761-4904
Email bcavanagh@aldeyra.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Part 1 ADX-629 (Open-label)
ADX-629 (250 mg) administered BID for 90 days

Locations
Country Name City State
United States Bexley Dermatology Research Bexley Ohio

Sponsors (1)
Lead Sponsor Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event (AE) Query Incidence and severity of AEs From Day 1 to Day 90
Secondary Investigator Global Assessment (IGA) Score Change from Baseline in IGA Score From Day 1 to Day 90
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