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)

NCT07355075 · tracked via the Priya Life Science USA tracker

Sponsor

Turn Therapeutics

Phase

Phase 2/3

Started

2025-07-11

Last updated

2026-09-04

Condition(s) studied

Eczema Atopic DermatitisEczemaAtopic Dermatitis

Investigational drug(s) / intervention(s)

GX-03Vehicle

GX-03: Topical ointment

Vehicle: Ointment carrier

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

vIGA-AD Success at Week 4 — At Day 28 (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 — At Day 28 (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 — At Day 56 (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 — At Day 56 (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.

Trial sites (1)

Facility	City	Region	Status
ALS Global	Irving	Texas	Recruiting

Other trials for the same condition

A Study Evaluating APG777 in Atopic Dermatitis Active, not recruiting

A Study of Barzolvolimab in Patients With Atopic Dermatitis Active, not recruiting

A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis Active, not recruiting

FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients Recruiting

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355075 on ClinicalTrials.gov ↗ ← All trials in the USA