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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Safety and tolerability: adverse events (AEs)
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
Time frame: Through study completion Day 225 (+7 days)
Safety and tolerability: laboratory abnormalities
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
Time frame: Through study completion Day 225 (+7 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
S. aureus CFU in target AD skin lesion
Time frame: 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
S. aureus qPCR in target AD skin lesion
Time frame: 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
Eczema Area and Severity Index of all lesional skin areas (range 0-72); higher score indicates worse atopic dermatitis
Time frame: 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
vIGA-AD
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Time frame: Day 1 through Day 71 (± 2 days)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) index in BX005-A vs vehicle groups
SCORing Atopic Dermatitis index of all lesional skin areas (range 0-103); higher score indicates worse atopic dermatitis
Time frame: 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
Local SCORing Atopic Dermatitis index (range 0-15); higher score indicates worse atopic dermatitis
Time frame: Day 1 through Day 71 (± 2 days)