NCT05240300撤回1 期
A Phase 1b/2a, Double-blind (Sponsor Open), Randomized, Vehicle-controlled Study of Topically Administered BX005-A in Subjects With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- BiomX, Inc.
- 入组人数
- 48
- 主要终点
- Safety and tolerability: adverse events (AEs)
研究概览
简要总结
The purpose of study BMX-05-001 is to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically in adult subjects with moderate to severe atopic dermatitis (AD).
详细描述
BMX-05-001 is a double-blind (Sponsor open), randomized, vehicle-controlled, first-in-human, Phase 1b/2a study to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically twice daily for 8 weeks to lesional areas in adult subjects with moderate to severe atopic dermatitis (AD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years old
- •Confirmed clinical diagnosis of active AD with at least a 6-month history and clinically stable AD for ≥ 1 month
- •Clinical diagnosis of moderate or severe AD with a vIGA-AD score of ≥ 3 and a lesion vIGA-AD score ≥ 3 in the target AD skin lesion
- •BSA with AD of 2%-30%, excluding scalp
- •Colonized with S. aureus in at least one AD skin lesion
- •Female subjects of non-childbearing potential must meet at least 1 of the following: postmenopausal status; documented hysterectomy and/or bilateral oophorectomy; or medically confirmed ovarian failure. All other female subjects (including those who have undergone tubal ligation) are of childbearing potential.
- •Female subjects of childbearing potential who have a negative urine pregnancy test
- •Effective contraceptive method for female subjects of childbearing potential and for male subjects
- •Able to understand study procedures and attend all study visits
- •Willing to refrain from use of all other systemic or topical agents for the treatment of AD or the prevention of complications of AD (e.g., secondary infection)
排除标准
- •Active skin infection and/or systemic infection requiring systemic or topical antimicrobial agents and/or a skin drainage procedure, or a history of recurrent bacterial skin infections
- •Other concurrent skin diseases which could interfere with the diagnosis and/or management of AD (e.g., psoriasis, contact dermatitis), or presence of open, chronic non-healing wounds in their treatable AD lesions
- •Known hypersensitivity to study drug, its excipients, simethicone, and/or any emollient to be used in study
- •Planned treatment with a prohibited medication during study, or received a prohibited medication within time frame noted below, prior to first dose of study drug:
- •Must be discontinued at least 28 Days prior to Day 1:
- •Systemic corticosteroids
- •Systemic JAK inhibitors and immunosuppressive agents
- •Nonbiologic investigational agent or device
- •Total body phototherapy
- •Must be discontinued at least 14 Days prior to Day 1:
- •Systemic antimicrobials
- •Probiotics and prebiotics
- •Prescription skin barrier repair products
- •Must be discontinued at least 7 Days prior to Day 1:
- •Topical therapies for AD
- •Topical antimicrobials and antiseptic cleansers
- •Use of antibacterial soaps or topical sodium hypochlorite-based products
- •Current emollient use (need to convert to study emollient 7 days prior to Day 1)
- •Currently being treated with biologic agents; exception: may be enrolled if dupilumab was discontinued at least 12 weeks prior to Day 1, or if other biologics were discontinued at least 5 half-lives prior to Day
- •Female subjects who are pregnant, breastfeeding, or planning a pregnancy, or are of childbearing potential and not using an effective and allowed form of contraception.
- •Enrolled in another investigational study 30 days prior to Screening or 90 days prior to Screening if investigational agent was a phage product.
- •Other medical and/or psychiatric conditions which makes the subject inappropriate for study participation, increases likelihood that the subject will not be able to comply with study therapy or procedures and/or which places the subject at undue risk
- •Active abuse of alcohol and/or illicit drugs or a history of such abuse that would make it difficult for the subject to comply with study and/or place subject at undue risk
- •Known infection with human immunodeficiency virus (HIV) or other immunodeficiency disorder.
- •Current or prior history of a malignant neoplasm other than previously treated non-melanoma skin cancer
研究组 & 干预措施
BX005-A
Experimental
twice daily topical application x 8 weeks
干预措施: BX005-A (Biological)
Vehicle
Placebo Comparator
twice daily topical application x 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability: adverse events (AEs)
时间窗: Through study completion Day 225 (+7 days)
The proportion of subjects with any AE, treatment-emergent AE (TEAE), serious adverse event, TEAE leading to study drug discontinuation, TEAE leading to study discontinuation, or death
Safety and tolerability: laboratory abnormalities
时间窗: Through study completion Day 225 (+7 days)
The proportion of subjects with abnormalities in laboratory parameters, graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
次要结局
- Change from baseline in SCORing Atopic Dermatitis (SCORAD) index in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
- Proportion of subjects who achieve a Validated Investigator Global Assessment AD (vIGA-AD) score of 0 or 1 with at least a 2-grade reduction from baseline in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
- Change from baseline in log S. aureus density, measured by quantitative PCR (qPCR)/cm2 in the target AD skin lesion in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
- % change from baseline in the Eczema Area and Severity Index (EASI) score in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
- Change from baseline in log S. aureus density, measured by colony forming units (CFU)/cm2 in the target AD skin lesion in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
- Change from baseline in SCORing Atopic Dermatitis (SCORAD) index of the target AD skin lesion in BX005-A vs vehicle groups(Day 1 through Day 71 (± 2 days))
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