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.
Adults aged 18 to 80 years, inclusive
Male or female subjects in good general health as determined by medical history
Baseline EASI Score of ≥ 1.1
Baseline vIGA-AD Score of 3 or 4
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
vIGA-AD Success at Week 4
vIGA-AD Success defined as score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-75 at Week 4
75% reduction from baseline in Eczema Area Severity Index (EASI) at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-90 at Week 8
90% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-100 at Week 8
100% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
Click on the lead sponsor to view all of their trials.
