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NCT05717920 | COMPLETED | Atopic Dermatitis

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

Condition or disease

Atopic Dermatitis

Intervention/treatment

ADX-629 (Open-label)

Phase

PHASE2

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
Estimated Enrollment : 8 participants
Masking : NONE
Masking Description : Part 1 is an open-label trial.
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-02-15
Estimated Primary Completion Date : 2023-11-21
Estimated Study Completion Date : 2023-11-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)

Location Details

NCT05717920

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Ohio

Bexley Dermatology Research

Bexley, Ohio, United States, 43209