RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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)

Sponsor: Turn Therapeutics • ClinicalTrials.gov ID: NCT07355075

Registry updated: 2026-09-04

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Description

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.

Interventions

GX-03 (Combination product)
Topical ointment
Vehicle (Other)
Ointment carrier

Eligibility criteria

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 * 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 Exclusion Criteria Individuals meeting any of the following criteria will be excluded: * 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 * Use of topical medications at the test sites within 72 hours prior to enrollment * Damaged or altered skin at or near test sites (e.g., sunburn, tattoos, scars, uneven pigmentation) that could confound evaluations * Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity

Conditions

Eczema Atopic Dermatitis Eczema Atopic Dermatitis

Locations

ALS Global — Irving, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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