Phase 2 Study of GX-03 Topical Ointment for Adults with Moderate to Severe Eczema Atopic Dermatitis

What this Trial Is About

Researchers are evaluating the effectiveness and safety of GX-03, a topical ointment, in adults with moderate to severe atopic dermatitis, also known as eczema. This Phase 2, randomized, double-blind, vehicle-controlled study plans to enroll up to 120 adults aged 18 to 80, with the possibility of expanding to 200 based on interim review by an Independent Data Monitoring Committee. The study focuses on improvements in disease severity, itch, and patient-reported eczema symptoms. Participants will be randomly assigned to receive either GX-03 ointment or a matching vehicle control ointment. The assigned treatment will be applied topically to affected skin areas at least twice daily for eight consecutive weeks. The study includes an adaptive design, with an interim assessment after about 50 participants complete the 8-week treatment or withdraw early, which could lead to continuation, expansion, or stopping of enrollment based on pre-set criteria. During the study, participants will attend visits at baseline, Week 4, and Week 8 for assessments using validated tools such as the Investigator Global Assessment, Eczema Area and Severity Index, Peak Pruritus Numeric Rating Scale, and Patient-Oriented Eczema Measure. Safety will be monitored through adverse event reporting, medication reviews, and weekly safety check-ins. The primary outcome is the change in Investigator Global Assessment at Week 8, and total participation will last for the 8-week treatment period.

A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema)