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

RECRUITING

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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.

Conditions:

Atopic Dermatitis

Study Start (Actual) 2023-02-15

Primary Completion (Estimated) 2024-12

Study Completion (Estimated) 2024-12

Enrollment (Estimated) 10

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Bexley, Ohio, United States

Eligibility Criteria

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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 Registration Dates

First Submitted2023-01-25
First Submitted that Met QC Criteria2023-02-06
First Posted2023-02-08

Study Record Updates

Last Update Submitted that Met QC Criteria2024-04-16
Last Update Posted2024-04-17
Last Verified2024-04