NCT05491447

A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis

A Phase 2 Clinical Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 Ointment in Adult Subjects With Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: BioMimetix JV, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BMX-010	Ointment
DRUG	Placebo	Ointment

Timeline

• Start date: 2023-01-08
• Primary completion: 2023-12-30
• Completion: 2024-04-15
• First posted: 2022-08-08
• Last updated: 2024-04-18

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study