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

Last updated: October 31, 2024
Sponsor: Aldeyra Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Hives (Urticaria)

Skin Infections/disorders

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Part 1 ADX-629 (Open-label)

ADX-629 (Open-label)

Clinical Study ID

NCT05717920
ADX-629-ATD-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atBaseline

  • Not pregnant, breastfeeding, or lactating and agree to use a highly effective methodof acceptable contraceptive for the trial duration, if applicable

Exclusion

Exclusion Criteria:

  • Presence of clinically significant kidney disease or an estimated gloverularfiltration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 duringscreening

  • History of any unstable chronic diseases/conditions, clinically significantabnormalities, or findings, that in the opinion of the Investigator, couldcompromise subject safety or affect the conduct of the trial

Study Design

Total Participants: 8
Treatment Group(s): 2
Primary Treatment: Part 1 ADX-629 (Open-label)
Phase: 2
Study Start date:
February 15, 2023
Estimated Completion Date:
November 21, 2023

Study 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.

Connect with a study center

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

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