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
Overview
- Phase
- Phase 1
- Intervention
- BX005-A
- Conditions
- Atopic Dermatitis
- Sponsor
- BiomX, Inc.
- Enrollment
- 48
- Primary Endpoint
- Safety and tolerability: adverse events (AEs)
- Status
- Withdrawn
- Last Updated
- 9 months ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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:
Arms & Interventions
BX005-A
twice daily topical application x 8 weeks
Intervention: BX005-A
Vehicle
twice daily topical application x 8 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability: adverse events (AEs)
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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))