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)

Overview

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.

This is a Phase 2, adaptive, randomized, double-blind, vehicle-controlled study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment (a non-systemic formulation containing polyhexanide) compared with matching vehicle control in adult participants with atopic dermatitis (AD). Stage 1 (Completed): Stage 1 enrolled 50 participants (53 subjects randomized, 50 completed) using broad severity eligibility criteria (baseline EASI \>7 or vIGA-AD 3 or 4) to evaluate treatment behavior and biomarker concordance across a wide spectrum of AD phenotypes. Following completion of the 8-week evaluation period in 50 participants, an unblinded interim review was conducted by an Independent Data Monitoring Committee (IDMC). Stage 2 (Active / Recruiting): Guided by Stage 1 findings, Stage 2 prospectively evaluates GX-03 in an expanded cohort of approximately 135 participants (target: 120 completing the study). Stage 2 enrollment is stratified across three baseline EASI severity bands (1.1-7.0, 7.1-15.9, and 16.0 or above) and enriched for participants with severe baseline PP-NRS of 7 or above). In both stages, eligible participants are randomized in a 1:1 ratio to receive topically applied GX-03 or matching vehicle control self-administered to affected skin areas at least twice daily for 8 consecutive weeks. Efficacy assessments are conducted at Week 4, and Week 8 using a superiority testing framework. To control the overall Type I error rate across multiple primary and key secondary endpoints in Stage 2, a Hochberg multiplicity adjustment procedure will be applied. Evaluated endpoints include: * Week 4 vIGA-AD Success (vIGA-AD Success defined as a score of 0 or 1 with at least 2 grade improvement). * Week 4 EASI-75 (EASI-75 defined as at least a 75% reduction in Eczema Area Severity Index) * Week 8 EASI-90 (EASI-90 defined as at least a 90% reduction in Eczema Area Severity Index) * Week 8 EASI-100 (EASI-100 defined as 100% reduction in Eczema Area Severity Index) Safety Monitoring: Safety assessments include treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), local site tolerability monitoring, and concomitant medication reviews across the treatment and follow-up periods.