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

NCT ID: NCT05717920

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-11-21

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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADX-629

Group Type: EXPERIMENTAL

ADX-629 (Open-label)

Intervention Type: DRUG

ADX-629 (250 mg) administered twice daily for 90 days

Interventions

ADX-629 (Open-label)

ADX-629 (250 mg) administered twice daily for 90 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bexley Dermatology Research

Bexley, Ohio, United States

Countries

United States

Other Identifiers

ADX-629-ATD-001

Identifier Type: -

Identifier Source: org_study_id