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) (GX-03 in AD)

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema; Atopic Dermatitis; Eczema Atopic Dermatitis
• Intervention / Treatment: Other: Vehicle; Combination product: GX-03

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Barry Reece, MS; Phone Number: 9728714371; Email: barry.reece@alsglobal.com

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75062
      • Recruiting
      • ALS Global
      • Contact: Jordan Williams; Phone Number: 9725732908; Email: jordan.williams@alsglobal.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GX-03; Treatment Arm	Combination product: GX-03; Topical ointment
Experimental: Vehicle; Vehicle Control	Other: Vehicle; Ointment carrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Day 28 (Week 4)
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.	At Day 28 (Week 4)
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.	At Day 56 (Week 8)
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.	At Day 56 (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Eczema Area and Severity (EASI) at Week 8	Change in EASI from Baseline to week 8	At Day 56 (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	At Day 56 (Week 8)
Patient-Oriented Eczema Measure (POEM) score at Week 8	Patient-Oriented Eczema Measure (POEM) questionnaire response at week 8	At Day 56 (Week 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Day 28 (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	At Day 28 (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	At Day 28 (Week 4)
Patient-Oriented Eczema Measure (POEM) score at Week 4	Patient-Oriented Eczema Measure (POEM) questionnaire response at Week 4	At Day 28 (Week 4)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Incidence, nature, severity, and causal relationship of treatment-emergent adverse events (TEAEs) from time of first application through the final visit.	Up to 8 Weeks (Treatment Period)

Collaborators and Investigators

• Sponsor: Turn Therapeutics

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema; Moderate-Severe AD; Moderate-Severe Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: Protocol/Panel 4604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Protection of participant privacy and re-identification risks Ongoing regulatory or commercial activities Intellectual property and competitive concerns Resource and practical barriers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No