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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- vIGA-AD Success at Week 4
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded, vehicle controlled
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vehicle
Vehicle Control
干预措施: Vehicle (Other)
GX-03
Treatment Arm
干预措施: GX-03 (Combination Product)
结局指标
主要结局
vIGA-AD Success at Week 4
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点