NCT04603027已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 26
- 主要终点
- Mean Percentage Change in PASI
研究概览
简要总结
This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis. This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥18 and ≤70 years old at the time of informed consent.
- •A documented diagnosis of plaque psoriasis for ≥6 months.
- •Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of ≥3% and ≤10% and meet both of the following additional criteria:
- •PASI score of ≥6 and ≤15, and
- •PGA score of 2 or
排除标准
- •Have a diagnosis of non-plaque psoriasis.
- •Plaque psoriasis restricted to scalp, palms, and soles only.
- •Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- •Unresponsive to prior use of biologics (including, but not limited to, TNFα inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T cells).
- •If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
- •Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to oral or injectable corticosteroids, retinoids, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of first administration of study drug. This includes therapeutic doses of non-steroidal anti-inflammatory drugs such as ibuprofen, although intermittent as required use as an analgesic is permitted when required. Chronic use of low dose aspirin for cardiovascular protection is permitted.
- •Currently receiving lithium, antimalarials, leflunomide, or IM gold, or have received lithium, antimalarials, IM gold, or leflunomide within 4 weeks of first administration of study drug.
- •Have used topical medications/treatments that could affect psoriasis or PGA evaluation (including [but not limited to] high- and mid-potency corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, picrolimus, and tacrolimus) within 2 weeks of the first administration of study drug. Topical unmedicated emollients and low-potency topical corticosteroids are not excluded.
- •Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.
- •Active inflammatory bowel disease.
- •Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).
- •Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study.
- •Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment).
- •Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.
- •History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening (includes stroke, transient ischemic attack, and coronary heart disease [angina pectoris, myocardial infarction, heart failure, revascularization procedures]).
- •Current acute or chronic inflammatory disease other than psoriasis or psoriatic arthritis (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus). If a subject is off all treatment and is disease and has been symptom free for greater than 12 months, then the inflammatory disease is considered to be in remission and they may be enrolled.
- •Hypersensitivity to P histicola or to any of the excipients.
- •Active untreated mental or psychiatric disorder. Participants who are on stable dosing of medication for a mental or psychiatric disorder for at least 6 months before screening and whose treating physicians consider them to be mentally stable may be enrolled.
- •Any major or minor GI surgery within 6 months of screening.
- •Any major surgery within 6 months of screening.
- •Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- •Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.
- •Initiating any OTC or prescription medication including vitamins, herbal supplements and nutraceuticals (eg, supplements including high doses of probiotics and prebiotics as usually found in capsules/tablets/powders), except acetaminophen/paracetamol and anti-histamines, within 14 days prior to baseline or anticipates change in dosage for the duration of the study period. Note that probiotic and prebiotic foods that contain low doses are allowed (eg, yoghurt, kefir, kombucha, however, supplements containing high doses of probiotics and prebiotics are not allowed at any point during the study.
研究组 & 干预措施
Cohort 1
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: EDP1815 (Drug)
Cohort 1
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: Placebo (Drug)
Cohort 2
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: EDP1815 (Drug)
Cohort 2
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: Placebo (Drug)
Cohort 3
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: EDP1815 (Drug)
Cohort 3
Experimental
75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10^11 cells, capsule, once daily, 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percentage Change in PASI
时间窗: 16 weeks
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.
次要结局
- Mean Absolute Change in DLQI(16 weeks)
- Mean Percentage Change in DLQI(16 weeks)
- Achievement of PASI-50(16 weeks)
- Time to First Achievement of PASI-50(20 weeks)
- Achievement of PASI-75(16 weeks)
- Achievement of PASI-90(16 weeks)
- Achievement of PASI-100(16 weeks)
- Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline(16 weeks)
- Achievement of PGA of 0(16 weeks)
- Mean Percentage Change in PGAxBSA(16 weeks)
- Mean Absolute Change in PGAxBSA(16 weeks)
- Mean Percentage Change in PASI(12 weeks)
- Mean Absolute Change in PASI(16 weeks)
- Mean Percentage Change in LSS(16 weeks)
- Mean Absolute Change in LSS(16 weeks)
- Mean Percentage Change in mNAPSI(16 weeks)
- Cumulative Incidence of Partial Relapse(40 weeks)
- Cumulative Incidence of Complete Relapse(40 weeks)
- Cumulative Incidence of Rebound(40 weeks)
- Mean Absolute Change in mNAPSI(16 weeks)
研究者
研究点 (26)
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