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)

Turn Therapeutics

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Atopic Dermatitis; Eczema Atopic Dermatitis; Eczema

Treatments: Combination Product: GX-03; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT07355075

Protocol/Panel 4604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups

GX-03

Experimental group

Description:

Treatment Arm

Treatment:

Combination Product: GX-03

Vehicle

Experimental group

Description:

Vehicle Control

Treatment:

Other: Vehicle