A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 59
- 主要终点
- Achievement of EASI-50
研究概览
简要总结
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.
详细描述
Atopic dermatitis (atopic eczema) is a very common type of skin disease. It typically causes red, dry, and itchy skin and may have a significant impact on quality of life. Rashes may appear on the arms and behind the knees, or anywhere else on the body. While there are existing therapies, there is currently no cure for atopic dermatitis.
This is a randomized, double blind, placebo controlled, parallel group, Phase 2 study to evaluate the efficacy and safety of EDP1815 in adult participants 18 to ≤75 years of age with mild, moderate, and severe atopic dermatitis (AD).
Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have mild, moderate, or severe AD involving at least 5% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of 2, 3, or 4; and an Eczema Area Severity Index (EASI) of at least 6 at screening and Day 1.
All participants must agree to use a background therapy (per protocol) twice daily for at least 14 days prior to Day 1 in order to be considered eligible for the study.
Approximately 405 participants will be randomized to receive either EDP1815 or placebo (295 to EDP1815: 110 to placebo) and treated for 16 weeks. Participants in Cohorts 1, 2, & 3 will be randomized in a 3:1 ratio (225 to EDP1815: 75 to placebo). Participants in Cohort 4 will be randomized in a 2:1 ratio (70 to EDP1815: 35 to placebo). Cohorts 1, 2 & 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, & 3 are completed.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Must meet age criteria.
- •Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
- •Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1:
- •An IGA of 2, 3 or 4 on the vIGA scale, and;
- •A BSA of ≥5%, and;
- •An EASI score of ≥
- •Must agree to use emollients.
- •Must meet contraception requirements.
排除标准
- •Have been in a clinical trial for EDP1815 prior to signing of ICF.
- •Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.
- •Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.
- •Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window.
- •Hypersensitivity to P histicola or to any of the excipients.
- •Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
- •Have any other conditions, which, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
研究组 & 干预措施
Cohort 1
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10^11 total cells) once daily for 16 weeks
干预措施: EDP1815 (Drug)
Cohort 1
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10^11 total cells) once daily for 16 weeks
干预措施: Placebo (Drug)
Cohort 2
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10^11 total cells) once daily for 16 weeks
干预措施: EDP1815 (Drug)
Cohort 2
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10^11 total cells) once daily for 16 weeks
干预措施: Placebo (Drug)
Cohort 3
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10^11 cells) twice daily (6.4 x 10^11 total cells) for 16 weeks
干预措施: EDP1815 (Drug)
Cohort 3
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10^11 cells) twice daily (6.4 x 10^11 total cells) for 16 weeks
干预措施: Placebo (Drug)
Cohort 4
105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10^10 total cells) once daily for 16 weeks
干预措施: EDP1815 (Drug)
Cohort 4
105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10^10 total cells) once daily for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Achievement of EASI-50
时间窗: 16 weeks
The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.
次要结局
- Percentage of Participants Achieving BSA-75(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving EASI-50(4, 8 and 12 weeks)
- Mean Percentage Change in EASI(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement(4, 8, 12, and 16 weeks)
- Mean Absolute Change in vIGA*BSA(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving EASI-90(4, 8, 12, and 16 weeks)
- Mean Absolute Change in EASI(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving vIGA of 0 or 1(4, 8, 12, and 16 weeks)
- Mean Percentage Change in vIGA*BSA(4, 8, 12, and 16 weeks)
- Mean Absolute Change From Baseline in BSA(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving BSA-50(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving EASI-75(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving vIGA of 0(16 weeks)
- Mean Percentage Change From Baseline in SCORAD(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving SCORAD-50(4, 8, 12, and 16 weeks)
- Mean Percentage Change From Baseline in BSA(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving BSA Reduction to 3% BSA or Less(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving SCORAD-75(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline(16 weeks)
- Number of Courses of Rescue Therapy Per Participant(4, 8, 12, and 16 weeks)
- Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD)(4, 8, 12, and 16 weeks)
- Mean Percentage Change From Baseline in DLQI(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline(16 weeks)
- Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline(16 weeks)
- Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)(4, 8, 12, and 16 weeks)
- Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline(16 weeks)
- Number of Days of Treatment With Rescue Therapy Per Participant(16 weeks)
- Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI)(4, 8, 12, and 16 weeks)
- Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score(4, 8, 12, and 16 weeks)
- Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)(4, 8, 12, and 16 weeks)
- Proportion of Participants Not Requiring Rescue Therapy(4, 8, 12, and 16 weeks)
- Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS)(4, 8, 12, and 16 weeks)