NCT03235024

Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD

Detailed description

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate). The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit. Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6). Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study. Investigators plan to enroll approximately 130 total patients. Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
BIOLOGICAL	B244	B244 suspension
BIOLOGICAL	Vehicle	Vehicle suspension

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-02-27
• Completion: 2019-03-20
• First posted: 2017-08-01
• Last updated: 2022-10-10
• Results posted: 2022-10-10

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study