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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)

Study acronym: GX-03 in AD
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jul 10, 2026 → Jan 20, 2027
Primary endpoints added 1 → 4 primary endpoints
See other at-risk trials from Turn Therapeutics

Record History

  1. Primary and study completion pushed from Jul 10, 2026 to Jan 20, 2027 Primary endpoint(s) modified · Phase changed: Phase 2 → Phase 2/3 · Enrollment increased: 110 → 190 participants · 3 morev4 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 2 → Phase 2/3
    • Enrollment increased: 110 → 190 participants
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints shortened, about 32 words
    • Study description shortened, about 46 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint(s) modified Primary completion pushed from May 31, 2026 to Jul 10, 2026 · Enrollment increased: 100 → 110 participants · Completion date: Jun 30, 2026 to Jul 10, 2026 · 4 morev3 Show 7 more changesShow less
    • Primary completion pushed from May 31, 2026 to Jul 10, 2026
    • Enrollment increased: 100 → 110 participants
    • Completion date: Jun 30, 2026 to Jul 10, 2026
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 170 words
    • Study title expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study description revisedv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07355075
Lead Sponsor Turn Therapeutics
Conditions Eczema Atopic Dermatitis, Eczema, Atopic Dermatitis
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov