NCT04490109

B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle (placebo) for 4 weeks.

Detailed description

This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle applications on treatment of mild to moderate pruritus associated with atopic dermatitis. * Approximately 576 subjects may be enrolled. * The total duration of the study will be approximately 11 weeks. Participants will report for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go through a two-week washout phase before reporting for a Baseline visit. * After screening and baseline, participants will be randomized to one of two doses of B244 or vehicle application for 4 weeks. * Randomization will be 1:1:1 so that an equal number of patients will be treated in each Arm of the study. * All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0 * Subjects must be willing and able to complete diary within a consistent time frame on a daily basis and to comply with restrictions on allowable therapies for the duration of the study. * All subjects will attend a screening visit not more than 21 days prior to Baseline (Day 0). * Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day 28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4 weeks (28 (±3) days) after the last dose of study medication. * Subjects will apply a total of 10 pumps of IP per application across all affected areas twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks. * Safety evaluations will consist of review of participant's medical history at screening and on-going assessment of adverse events reported throughout the study duration.

Conditions

• Atopic Dermatitis
• Pruritus

Interventions

Type	Name	Description
BIOLOGICAL	B244	B244 suspension
BIOLOGICAL	Vehicle	Vehicle suspension

Timeline

• Start date: 2020-06-24
• Primary completion: 2021-12-10
• Completion: 2022-01-07
• First posted: 2020-07-28
• Last updated: 2025-01-28
• Results posted: 2024-12-19

Locations

56 sites across 1 country: United States

Regulatory

• FDA-regulated drug study