A Double-Blind, Vehicle-Controlled Study to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals With Moderate to Severe Eczema
This is a Phase 2, two-stage, adaptive, 1:1 randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment in adult subjects with atopic dermatitis (eczema). Stage 1 (Completed): Stage 1 comprised an initial cohort of 50 subjects evaluated through Week 8. Following a pre-specified interim analysis conducted under the supervision of Independent Data Monitoring Committee (IDMC), treatment-response patterns, safety profiles, and endpoint parameters were assessed to optimize enrollment criteria and outcome measures for Stage 2. Stage 2 (Active/Recruiting): Stage 2 plans to enroll approximately 135 subjects across three baseline EASI severity strata (1.1 to 7.0, 7.1 to 15.9, and 16.0 and above) with a target of at least 120 subjects completing the 8-week treatment period. Enrollment for Stage 2 is specifically enriched for subjects presenting with significant pruritus (baseline Peak Pruritus Numeric Rating Scale \[PP-NRS\] of 7 or more) and baseline EASI of 1.1 or more.
∙ Participants must meet all of the following criteria:
• Adults aged 18 to 80 years, inclusive
• Male or female subjects in good general health as determined by medical history
• Subjects meeting all of the following baseline criteria:
‣ Baseline EASI Score of ≥ 1.1
⁃ Baseline vIGA-AD Score of 3 or 4
⁃ Baseline PP-NRS Score of ≥ 7
• Ability to read, understand, and provide written informed consent in English
• Willingness and ability to comply with study procedures, including study visits and daily topical application
• Agreement to use only the assigned study product on designated areas of interest for the duration of the study