Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.
Group 1 is an open-label safety cohort to determine the PK profile of the active study drug, BMX-010 ointment. At least 3 and up to 12 subjects will be enrolled to analyze the safety and pharmacokinetics of BMX-010 ointment. If a subject cannot complete the required PK blood draws, another subject will be enrolled to ensure at least 3 subjects complete the PK blood draws. Subjects will not be randomized and all subjects in this group will be dispensed BMX-010. Dispensing information will be provided by IWRS. Study drug will be administered in clinic on Day 1 and also Day 8 (the first study drug application of the day) in order to obtain pre-dose PK blood draws. Once a minimum of 3 subjects complete all of the PK blood draws (through Day 8) and the data is analyzed, the Clinical Safety Committee (CSC) will review and determine if enrollment to Group 2 can begin. Enrollment of subjects into Group 2 will not begin until the PK and safety data from a minimum of three subjects enrolled in Group 1 is obtained and analyzed, and proceeding with Group 2 has been approved by the sponsor. Once enrollment in Group 2 begins, the subjects will be randomized into Arm A, B, or C. Group 2 is a randomized, partially blinded (where neither the subjects nor the appropriate clinical center staff are told which treatment or intervention participants are receiving), placebo-controlled cohort designed to further test the safety and efficacy of BMX-010 ointment vs. placebo. Up to approximately 216 adult subjects with AD will be enrolled. At the baseline visit, subjects will be randomized to receive BMX-010 (0.5% or 0.1%) or placebo in a 1:1:1 ratio, by a permuted block randomization schema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
103
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States
Dermatology Trial Associates
Change from Baseline in Eczema Area and Severity Index at Week 4
Evaluate the change in Eczema Area and Severity Index score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle from baseline to week 4.
Time frame: 28 days
Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters
Compare treatment emergent adverse events, as well as changes from baseline in vital signs and clinical laboratory parameters in subjects with active AD receiving BMX-010 0.5% and 0.1% ointment compared with vehicle.
Time frame: 28 days
Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.
Evaluate the change in Eczema Area and Severity Index score subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, and 3.
Time frame: 21 days
Proportion of subjects who achieve Eczema Area and Severity Index-50 and Eczema Area and Severity Index -75 at Weeks 1, 2, 3 and 4.
Eczema Area and Severity Index-50 and Eczema Area and Severity Index-75 measures indicate the proportion of subjects with active AD with improvement over 50% and 75% based on the Eczema Area and Severity Index at weeks 1, 2, 3, and 4 in subjects treating with BMX-010 0.5% and BMX-010 0.1% compared to vehicle .
Time frame: 28 days
Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4
Evaluate the change in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scores in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
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Time frame: 28 days
Change from baseline in body surface area at Weeks 1, 2, 3, and 4.
Evaluate the change in Body Surface Area in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Time frame: 28 days
Change from baseline in validated Investigator Global Assessment of Atopic Dermatitis at Weeks 1, 2, 3, and 4.
Evaluate the change in validated Investigator Global Assessment of Atopic Dermatitis score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Time frame: 28 days
Proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4.
Evaluate the proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Time frame: 28 days
Change from baseline in the Pruritus Numerical Rating Scale (NRS) at Weeks 1, 2, 3, and 4.
Evaluate the change in the Pruritus Numerical Rating Scale score from baseline to weeks 1, 2, 3, and 4 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle.
Time frame: 28 days
Change from baseline in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) on Day 1.
Evaluate the change in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) compared to the pre-dose value on Day 1 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle.
Time frame: 1 day
Measurement of plasma concentrations of BMX-010 in participants receiving active treatment
Pharmacokinetic plasma samples will be collected on Day 1 and Day 8 at pre-dose and 1 and 3 hours post dose to evaluate the systemic exposure profile and pharmacokinetic (PK) behavior of BMX-010 under the conditions of this trial.
Time frame: 8 days