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 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: Protocol/Panel 4604
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis; Eczema; Eczema Atopic Dermatitis

Keywords

Moderate-Severe AD; Moderate-Severe Eczema; Eczema; Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

GX-03

EXPERIMENTAL

Treatment Arm

Combination Product: GX-03

Vehicle

EXPERIMENTAL

Vehicle Control

Other: Vehicle

Interventions

GX-03 COMBINATION_PRODUCT

Topical ointment

GX-03

Vehicle OTHER

Ointment carrier

Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Turn Therapeutics: lead

Study Sites (1)

ALS Global

Irving, Texas, 75062, United States

RECRUITING

Related Links

• Sponsor Website

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Barry Reece, MS

CONTACT

9728714371; barry.reece@alsglobal.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded, vehicle controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The test article will be distributed to study participants and each participant instructed to use the test article on an area of interest. Each subject will be evaluated using the EASI severity scale, vIGA-AD™ scoring system, and PP-NRS score. Evaluations will occur at baseline and again after 4 and 8 weeks of daily use.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 21, 2026
• Study Start: July 11, 2025
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)