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

October 31, 2024 updated by: Aldeyra Therapeutics, Inc.

The ADRO Trial: An Adaptive, 2-Part, Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Adults With Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADX-629
Drug: ADX-629 (Open-label)
ADX-629 (250 mg) administered twice daily for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event (AE) Query
Time Frame: From Day 1 to Day 90
Incidence and severity of AEs
From Day 1 to Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment (IGA) Score
Time Frame: From Day 1 to Day 90
Change from Baseline in IGA Score
From Day 1 to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aldeyra Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

November 21, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-629-ATD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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