NCT05717920

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ADX-629 (Open-label)	ADX-629 (250 mg) administered twice daily for 90 days

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-11-21
• Completion: 2023-11-21
• First posted: 2023-02-08
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study