This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks.
The study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM).
An interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.
Adults aged 18 to 80 years, inclusive
Male or female subjects in good general health as determined by medical history
Eczema Area and Severity Index (EASI) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™)
Ability to read, understand, and provide written informed consent in English
Pregnant, breastfeeding, or planning pregnancy during the study
Presence of any skin condition or dermatologic disease that could interfere with study treatment or assessments
Use of systemic or topical immunosuppressive therapies, including corticosteroids, within 3 weeks prior to enrollment
Use of anti-inflammatory medications (e.g., topical steroids, ibuprofen, celecoxib); steroid nasal or ophthalmic drops are permitted
Parallel
GX-03
Combination productTopical ointment
Vehicle
Other interventionOintment carrier
Change in Investigator Global Assessment (IGA) at Week 8
vIGA-AD score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 8
Change in Baseline Eczema Area and Severity (EASI) at Week 8
Change in EASI from Baseline to week 8
≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 8
≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to week 8
Patient-Oriented Eczema Measure (POEM) score at Week 8
Patient-Oriented Eczema Measure (POEM) questionnaire response at week 8
Change from baseline in Validated Investigator Global Assessment (vIGA-AD) at Week 4
vIGA-AD score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4
Change from Baseline in Eczema Area Severity Index (EASI) at Week 4
Change from Baseline in Eczema Area Severity Index (EASI) at Week 4
≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 4
≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to week 4
Patient-Oriented Eczema Measure (POEM) score at Week 4
Patient-Oriented Eczema Measure (POEM) questionnaire response at Week 4
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